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The LightScalpel LS-2010 SX, LS-2010 DX CO2 Laser Systems are intended for use intended for use in laser surgery procedures for incision, excision, vaporization, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology.

Intended uses specific to the LS-2010 FX and LS-2010 DX in fractional mode are indicated by **.

Dermatology / Plastic Surgery:

Ablation, and Vaporization of soft tissue for performance of or treatment of: laser dermabrasion: laser burn debridement; wrinkles*, and furrows**; textural irregularities**; vascular dyschromia**; and benign pigmented lesions **

Intended uses specific to the LS-2010 SX and LS-2010 DX in surgical mode are listed below.

Dental Surgery:

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; a heat source to activate tooth bleaching materials: Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium).

Oral Surgery:

Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision when used with antibiotic therapy.

General and Thoracic Surgery:

Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: debridement of decubitus ulcers, stasis, diabetic, and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectorny; 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.

Dermatology / Plastic Surgery:

Incision, Excision, Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing: laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; textural irregularities; keratosis, including actinic and sebortheic keratosis, sebortheci wart, and verruca seborrheica; vermillionecomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis; including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson's freckle; uneven pigmentation/vascular dyschromia;; surgical scars; keloids, including acne keloidalis nuchae; hemangiomas, including Buccal, port wine, and pyogenic granuloma, pyogenicum/granuloma telagiectatioum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; benign pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; thinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial natrixectomy; benign vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungual warts; blepharoplasty; and hair transplantation site preparation.

Gynecology / Genitourinary:

Incision, excision, ablation, and/or vaporization of soft tissue 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 tumors; hemangiomas; benign lesions of external genitalia; condyloma; phimosis; erythroplasia.

Gyn Laparoscopic Surgery:

Laser incision, excision, vaporization, and photocoagulation of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Otorhinolaryngology / ENT:

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, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsiller cryptolysis and neoplasma) and topsil ablation / tonsillotomy; benign tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatits nondularis chronica helices / Winkler's disease;

uvulopalatoplasty (LAUP, laser UPPP); 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

Podiatry:

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 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

Orthopedic Surgery:

Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectorny; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal.

Neurosurgery:

Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectomy; benign tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach).

The LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX laser systems are mobile platforms that utilize a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength. Output parameters are summarized in Table 1. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel.

A "calibration port" on the side of the laser systems allows checking and setting the power emitted from the distal laser aperture to the internal power meter and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below (7):

The laser systems have safety features complying with requirements in 21 CFR 1040. Performance Standards for Light Emitting Products.

Primary safety features are as follows:

System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling.

Laser system physical characteristics are: Delivery System:

LS-2010 SX, Flexible Fiber Waveguide; ~ 0.75mm ID, Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips.

LS-2010 FX & DX; Flexible Fiber Waveguide; ~ 0.50mm ID, Handpiece with internal beam steering galvanometers and laser diode aiming beam.

Purge Gas: Internal air pump purge through the Fiber and Handpiece.

System Cooling: Air; two thermostatically controlled fans with over-temperature protection.

Mobility: 4 wheels and handgrip on console for convenient system positioning.

This document is a 510(k) summary for the LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems. It establishes substantial equivalence by comparing the device to predicate devices and provides non-clinical performance data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable table as one might find for a software or diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices in several technological characteristics. The "performance" is implicitly deemed acceptable if these technological characteristics are sufficiently similar to those of legally marketed predicate devices.

The table below summarizes the technological characteristics compared across the new devices and predicate devices. The "reported device performance" is essentially the listed specifications of the LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. The submission is for a laser surgical instrument, and the evaluation relies on a comparison of technological characteristics and non-clinical bench testing, not a clinical study with a patient "test set".
• Data Provenance: Not applicable in the context of patient data. The non-clinical performance data is generated internally by LightScalpel LLC through "electrical safety and output characteristics" testing (Bench Testing section). The country of origin of the data would be the US, where LightScalpel LLC is located. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is not an AI/diagnostic device that requires expert-established ground truth on a test set. The "ground truth" for the device's technical specifications is established through internal engineering and testing processes. The FDA's review process itself involves experts in medical device regulation and technology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no "test set" in the context of clinical images or patient cases requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a conventional CO2 laser surgical instrument, not an AI-assisted diagnostic or clinical decision support tool. Therefore, an MRMC study related to AI improvement is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device has no standalone algorithmic component for performance evaluation without human interaction. Its performance is directly tied to its physical operation and energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the technical comparison: The "ground truth" for the comparison is the published technical specifications of the predicate devices, which have already gone through regulatory clearance and are considered substantially equivalent for their intended uses.
• For the new device's performance: The ground truth for the device's own reported performance values (e.g., power output, wavelength) is established through internal "electrical safety and output characteristics" bench testing, as stated in Section 8 of the summary. This would involve calibrated measurement equipment and adherence to recognized standards for laser performance testing.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. There is no training set for this device.

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