# K201387: Ultrafast, Ultrafast Plus, Ultrafast Lite

- Pathway: 510(k) (Traditional)
- Applicant: Dentlight, Inc.
- Decided: Feb 26, 2021 after 275 days
- Product code: NVK (Laser, Dental, Soft Tissue)
- 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: 21 generations back to K943450 (1995). 266 ancestors in all.
No later device cites it as a predicate yet.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081214: Styla Microlaser and Stylaortho, Zap Lasers, LLC (2008) Summary page 4.
- K200693: K2 Mobile, Hulaser, Inc. (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
Dental soft tissue indications: incision, excision, vaporization, ablation, and coagulation of oral soft tissues including the following: Gingival troughing for crown impression Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and ulcers Vestibuloplasty Tissue retraction for impression Laser periodontal indications including: Sulcular debridernent (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility). Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket.

Source page: https://510kreport.com/device/K201387
Methodology: https://510kreport.com/methodology