# K131805: Inpulse Laser

- Pathway: 510(k) (Special)
- Applicant: Incisive, Inc.
- Decided: Jul 18, 2013 after 29 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: 8 generations back to K936109 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 1.

## Indications for use
The InPulse LaserTm 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 lENT surgery, and dermatology & plastic surgery including intracral 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 InPulse FootLaser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophylon rubrum and T'. mentagrophytes, and/or yeasts Candida albicans, etc.). Dermatolojzv 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 Oroo~harangeal/ Dental Surp-erv Indicated for: *Abscess incision and drainage *Aphthous ulcers treatment *Biopsies, excisional and incisional *Crown lengthening *Exposure of unerupted I partially erupted teeth *Fibromfi removal * Frenectomy - Frenotomy *Gingival incision and excision *Gingivectomy *Gingivoplasty * Hemostasis * Implant removal *Lesion (tumor) removal * Leukoplakia *Operculectomy *Oral papillectomy * Pulpotomy *Pulpotomy as adjunct to root canal therapy *Removal of fzllingmnateriall 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 retraction for impressions * Vestibuloplasty General Surgery Indicated for: Open, laparoscopic, and endoscopic uI;DsLugauabation, vaporization, incision, excision, and coagulation of soft tissue) including: * Cholecystectomy Lymphadenectomy Mastectomy * Partial nephrectoniy * Hepatectomy * Pilonidal cystectomy Pancreatectomy Resection oflipoma Splenectomy * Pelvic adhesiolysis Hemorrhoidectomy Removal of lesions Thyroidectomy Removal of polyps Parathyroidectomy Removal oftumors Herniorrhaphy 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/K131805
Methodology: https://510kreport.com/methodology