LightScalpel CO2 lasers are FDA 510(k) cleared for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in 10 medical specialties: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology (ENT), plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology.

The indications below apply to the LightScalpel Pediatric Laser (LS-1005), Surgical Laser (LS-2010), and Premium Laser (LS-4020) CO2 laser systems under FDA 510(k) clearances K141658 and K213669, with the dental and oral surgery indications first established under K132661. These systems use 10.6 µm RF-excited CO2 laser technology with flexible fiber waveguide delivery. They are classified as Class II laser surgical instruments under 21 CFR 878.4810 (product code GEX) and are prescription devices.

Source: FDA 510(k) summaries and Indications for Use forms. Last reviewed .

Dental surgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for the following dental surgery procedures:

  • Gingivectomy (removal of hyperplasias)
  • Gingivoplasty
  • Papillectomy
  • Vestibuloplasty
  • Epulis
  • Sulcular debridement
  • Removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue)
  • Extraction site hemostasis
  • Treatment of ulcerous lesions, including aphthous ulcers
  • Heat source to activate tooth bleaching materials
  • Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium)

Source: FDA K132661, K141658, and K213669.

Oral surgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for the following oral surgery procedures:

  • Frenum release / frenectomy
  • Abscess (drainage)
  • Flap surgery
  • Biopsy (incisional and excisional)
  • Aphthous ulcers (incision and excision)
  • Excision and ablation of lesions, benign and malignant lesions, oral cavity tumors, and hemangiomas
  • Salivary gland pathologies
  • Preprosthetic gum preparation
  • Leukoplakia
  • Partial glossectomy
  • Periodontal gum resection
  • Hemostasis
  • Operculectomy
  • Crown lengthening (soft tissue)
  • Incision of infection when used with antibiotic therapy
  • Extraction site hemostasis

Source: FDA K132661, K141658, and K213669.

Dermatology and plastic surgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for incision, excision, ablation, and vaporization of soft tissue in dermatology and plastic surgery, for performance of or treatment of:

  • Laser skin resurfacing
  • Laser dermabrasion
  • Laser burn debridement
  • Wrinkles, rhytids, and furrows
  • Keratosis, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica
  • Vermilionectomy of the lip
  • Cutaneous horns
  • Solar / actinic elastosis
  • Cheilitis, including actinic cheilitis
  • Lentigines, including lentigo maligna or Hutchinson’s malignant freckle
  • Uneven pigmentation / dyschromia
  • Acne scars
  • Surgical scars
  • Keloids, including acne keloidalis nuchae
  • Hemangiomas, including buccal, port wine, and pyogenic granulomas / granuloma pyogenicum / granuloma telangiectaticum
  • Tattoos
  • Telangiectasias
  • Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
  • Superficial pigmented lesions
  • Adenosebaceous hypertrophy or sebaceous hyperplasia
  • Rhinophyma reduction
  • Cutaneous papilloma (skin tags)
  • Milia
  • Debridement of eczematous or infected skin
  • Basal and squamous cell carcinoma, including keratoacanthomas, Bowen’s disease (erythroplasia of Queyrat), and Bowenoid papulosis (BP) lesions
  • Nevi, including spider, epidermal, and protruding
  • Neurofibromas
  • Laser de-epithelialization
  • Trichoepitheliomas
  • Xanthelasma palpebrarum
  • Syringoma
  • Complete or partial nail matrixectomy
  • Benign / malignant vascular / avascular skin lesions
  • Mohs surgery
  • Lipectomy
  • Verrucae and seborrhoecae vulgares, including paronychial, periungual, and subungual warts
  • Blepharoplasty
  • Hair transplantation site preparation

Source: FDA K141658 and K213669.

Otorhinolaryngology (ENT)

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for laser incision, excision, ablation, vaporization, and/or photocoagulation of soft tissue in otorhinolaryngology for treatment of:

  • Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue
  • Adult and juvenile papillomatosis polyps
  • Lymphangioma removal
  • Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords
  • Stenosis, including subglottic stenosis
  • Tonsillectomy (including tonsillar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy
  • Benign and malignant tumors and fibromas (oral)
  • Superficial lesions of the ear, including chondrodermatitis nodularis chronica helicis (Winkler’s disease)
  • Uvulopalatoplasty (LAUP, laser UPPP)
  • Turbinectomy and turbinate reduction / ablation
  • Septal spur ablation / reduction and septoplasty
  • Partial glossectomy
  • Tumor resection of oral, subfacial, and neck tissues
  • Rhinophyma
  • Verrucae vulgares (warts)
  • Gingivoplasty / gingivectomy

Source: FDA K141658 and K213669.

General and thoracic surgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for:

  • Debridement of decubitus, stasis, diabetic, and other ulcers
  • Mastectomy
  • Debridement of burns
  • Rectal and anal hemorrhoidectomy
  • Breast biopsy
  • Reduction mammoplasty
  • Cytoreduction for metastatic disease
  • Laparotomy and laparoscopic applications
  • Mediastinal and thoracic lesions and abnormalities
  • Skin tag vaporization
  • Atheroma
  • Cysts, including sebaceous and pilar cysts, and mucous cysts of the lips
  • Pilonidal cyst removal and repair
  • Abscesses
  • Other soft tissue applications

Source: FDA K141658 and K213669.

Gynecology and genitourinary

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for incision, excision, ablation, and/or vaporization of soft tissue in gynecology and genitourinary procedures for treatment of:

  • Conization of the cervix, including cervical intraepithelial neoplasia and vulvar and vaginal intraepithelial neoplasia
  • Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa
  • Leukoplakia (vulvar dystrophies)
  • Incision and drainage of Bartholin’s and nabothian cysts
  • Herpes vaporization
  • Urethral caruncle vaporization
  • Cervical dysplasia
  • Benign and malignant tumors
  • Hemangiomas
  • Benign and malignant lesions of external genitalia
  • Phimosis
  • Erythroplasia

Source: FDA K141658 and K213669.

Gynecologic laparoscopic surgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for laser incision, excision, vaporization, and photocoagulation of soft tissue in gynecologic laparoscopic surgery for treatment of:

  • Endometrial lesions, including ablation for endometriosis
  • Excision / lysis of adhesions
  • Salpingotomy
  • Oophorectomy / ovariectomy
  • Fimbrioplasty
  • Metroplasty
  • Uterine myomas and fibroids
  • Ovarian fibromas and follicle cysts
  • Uterosacral ligament ablation
  • Hysterectomy

Source: FDA K141658 and K213669.

Podiatry

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for laser excision, ablation, and/or vaporization of soft tissue in podiatry for the reduction, removal, and/or treatment of:

  • Verrucae vulgares / plantar warts, including paronychial, periungual, and subungual warts
  • Fungal nail treatment
  • Matrixectomy, partial and complete
  • Porokeratoma ablation
  • Neuromas / fibromas, including Morton’s neuroma removal
  • Ingrown toenail treatment
  • Debridement of ulcers
  • Treatment of other soft tissue lesions

Source: FDA K141658 and K213669.

Orthopedic surgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for laser incision, excision, ablation, and/or vaporization of soft tissue in orthopedic surgery. Applications include:

  • Meniscectomy
  • Chondromalacia ablation
  • Chondroplasty
  • Ligament release (lateral and other)
  • Excision of plica
  • Partial synovectomy
  • Debridement of traumatic wounds
  • Debridement of decubitus and diabetic ulcers
  • PMMA removal

Source: FDA K141658 and K213669.

Neurosurgery

The LightScalpel Pediatric Laser LS-1005, Surgical Laser LS-2010, and Premium Laser LS-4020 are FDA 510(k) cleared for laser incision, excision, ablation, and/or vaporization of soft tissue in neurosurgery for the treatment of:

  • Posterior fossa tumors
  • Peripheral neurectomy
  • Benign and malignant tumors and cysts (e.g., gliomas, meningiomas including basal tumors, acoustic neuromas, lipomas, and large tumors)
  • Arteriovenous malformation
  • Pituitary gland tumors (transsphenoidal approach)

Source: FDA K141658 and K213669.

Urology

Urology is named in the general indication statement of every LightScalpel 510(k) clearance. The FDA documents group urologic procedures with gynecology under Gynecology and genitourinary, where the cleared indications for the Pediatric Laser (LS-1005), Surgical Laser (LS-2010), and Premium Laser (LS-4020) include:

  • Urethral caruncle vaporization
  • Phimosis
  • Erythroplasia

Source: FDA K141658 and K213669.

LightScalpel FDA 510(k) clearance history

LightScalpel has received four FDA 510(k) clearances for its CO2 laser systems. K141658 established the full set of indications on this page, and K213669 extended them to the LS-4020.

510(k)ClearedModelsPower (CW)Scope
K123037LS-10 (later LS-1005)2–10 WGeneral soft tissue indication in general surgery, dermatology, gynecology, oral surgery, ENT, plastic and reconstructive surgery, podiatry, and urology
K132661LS-1005 (Pediatric Laser)2–10 WAdded dentistry and detailed dental and oral surgery procedure indications
K141658LS-1005 (Pediatric Laser),
LS-2010 (Surgical Laser)		2–10 W /
2–20 W		Added orthopedic surgery and neurosurgery, and detailed procedure lists for every specialty
K213669LS-4020 (Premium Laser)2–40 WSame indications as K141658, extended to the dual-tube LS-4020

Common questions

Which LightScalpel lasers are FDA cleared?
The LightScalpel Pediatric Laser (LS-1005), Surgical Laser (LS-2010), and Premium Laser (LS-4020) CO2 laser systems. The LS-1005 and LS-2010 are cleared under K141658, and the LS-4020 under K213669. All three share the same indications for use.
Is the LightScalpel CO2 laser FDA-cleared for frenectomy?
Yes. Frenum release / frenectomy is a cleared oral surgery indication for the LightScalpel LS-1005, LS-2010, and LS-4020 under K141658 and K213669.
Is the LightScalpel CO2 laser FDA cleared for Laser Assisted New Attachment Procedure?
Yes. Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium) is a cleared dental surgery indication, first under K132661 and carried forward under K141658 and K213669.
Is the LightScalpel CO2 laser FDA cleared for ENT procedures?
Yes. Cleared ENT indications for the LS-1005, LS-2010, and LS-4020 (K141658, K213669) include tonsillectomy and tonsil ablation / tonsillotomy; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction / ablation; septal spur ablation / reduction and septoplasty; partial glossectomy; and removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx, and trachea.
Is the LightScalpel CO2 laser FDA cleared for urology?
Yes. Urology is named in the general indication statement of every LightScalpel clearance. Cleared genitourinary indications under K141658 and K213669 include urethral caruncle vaporization, phimosis, and erythroplasia.
How are LightScalpel lasers classified by the FDA?
As Class II laser surgical instruments under 21 CFR 878.4810 (product code GEX) for prescription use only.

Indications are listed as cleared by the U.S. Food and Drug Administration through the 510(k) premarket notification process. Some spellings and formatting have been standardized from the original FDA documents for readability. LightScalpel lasers are prescription devices intended for use by trained, licensed practitioners.