# K093545: Pinpointe Footlaser Model 6W, 30W, 100W

- Pathway: 510(k) (Traditional)
- Applicant: Incisive, Inc. (Formerly Named Incisive, LLC)
- Decided: Oct 15, 2010 after 332 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K936109 (1994). 33 ancestors in all.
122 later devices descend from it; 4 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083215: Incisive Family of Inpulse ND:Yag Lasers, Incisive, LLC (2009) Summary page 1.
- K083616: Patholase Family of Pinpointe and Pinpointe  Footlaser ND: Yag Lasers, Patholase, Inc. (2009) Summary page 1.

## Most influential descendants
- K103626: Cutera Genesisplus Laser System (2011), 121 descendants of its own
- K113702: Fotona XP ND: Yag Laser System (2012), 65 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K113810: Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules (2012), 34 descendants of its own
- K133837: Viora V-Total (2014), 33 descendants of its own

## Indications for use
The PinPointe FootLaser and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery. Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: * Matrixectomy * Periungual and subungual warts * Plantar warts * Radical nail excision * Neuromas The PinPointe FootLaser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Dermatology and Plastic Surgery Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: * Lesions of skin and subcutaneous tissue * Telangiectasia * Port wine lesions * Spider veins * Hemangiomas * Plantar warts * Periungual and subungual warts * Removal of tattoos * Debridement of decubitus ulcer * Treatment of keloids Oropharangeal / Dental Surgery Indicated for: * Abscess incision and drainage * Aphthous ulcers treatment * Biopsies, excisional and incisional * Crown lengthening * Exposure of unerupted / partially erupted teeth * Fibroma removal * Frenectomy * Frenotomy * Gingival incision and excision * Gingivectomy * Gingivoplasty * Hemostasis * Implant recovery * Lesion (tumor) removal * Leukoplakia * Operculectomy * Oral papillectomy * Pulpotomy * Pulpotomy as adjunct to root canal therapy * Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment * Selective ablation of enamel (first degree) caries removal * Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility * Tissue refraction for impressions * Vestibuloplasty General Surgery Indicated for: * Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Cholecystectomy - Lymphadenectomy - Mastectomy - Partial nephrectomy - Hepatectomy - Pilonidal cystectomy - Pancreatectomy - Resection of lipoma - Splenectomy - Pelvic adhesiolysis - Hemorrhoidectomy - Removal of lesions - Thyroidectomy - Removal of polyps - Parathyroidectomy - Removal of tumors - Hemiorrhaphy - Tumor biopsy - Tonsillectomy - Debridement of decubitus ulcers - Appendectomy Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: * Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues * Tonsillectomy * Adenoidectomy

Source page: https://510kreport.com/device/K093545
Methodology: https://510kreport.com/methodology