# K081214: Styla Microlaser and Stylaortho

- Pathway: 510(k) (Traditional)
- Applicant: Zap Lasers, LLC
- Decided: May 14, 2008 after 14 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: 6 generations back to K922901 (1992). 24 ancestors in all.
50 later devices descend from it; 8 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021227: Softlase G2-Surgical Diode Laser System, Zap Lasers, LLC (2002) Summary page 2.
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007) Summary page 2.
- K061898: Ezlase, Biolase Technology, Inc. (2007) Summary page 2.

## Most influential descendants
- K093852: Ezlase 3 Laser System (2010), 35 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own
- K180044: SIROLaser Blue (2018), 12 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own

## Indications for use
The Styla MicroLaserTM/StylaOrthoTM is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The Styla MicroLaserTm/StylaOrthoTM is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed: -Excision and Incision Biopsies -Hemostatic assistance -Treatment of Apthous Ulcers -Frenectomy -Frenotomy -Gingival Incision and Excision -Gingivectomy -Gingivoplasty -Incising and Draining of Abscesses -Operculectomy -Oral Papillectomy -Removal of Fibromas -Soft Tissue Crown Lengthening -Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) -Tissue retraction for Impression -Vestibuloplasty -Light activation of bleaching materials for teeth whitening -Laser-assisted bleaching/whitening of teeth

Source page: https://510kreport.com/device/K081214
Methodology: https://510kreport.com/methodology