# K151763: PerioLase Nd:YAG Pulsed Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Dental Technologies, Inc.
- Decided: Mar 15, 2016 after 260 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: 1 generation back to K030290 (2004). 1 ancestor in all.
22 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030290: Periolase  ND:Yag Dental Laser System, Millennium Dental Technologies, Inc. (2004) Summary page 5.

## Most influential descendants
- K172819: LightWalker Laser System Family (2017), 20 descendants of its own
- K191554: LightWalker Laser System Family (2019), 19 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K193661: LightWalker Laser System Family (2020), 8 descendants of its own
- K202985: LightWalker Laser System Family (2021), 7 descendants of its own

## Indications for use
The PerioLase Nd:YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization 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 and plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed: Oropharyngeal • Abscess incision and drainage • Aphthous ulcers treatment • Biopsies excision and incision • Crown lengthening • Hemostatic assistance • Fibroma removal • Frenectomy • Frenotomy • Gingival incision and excision • Gingivectomy • Gingivoplasty • Operculectomy • Oral papillectomy • Tissue retraction for impression • Vestibuloplasty • Selective ablation of enamel (first degree) caries • Exposure of unerupted / partially erupted teeth • Implant recovery • Lesion (tumor) removal • Leukoplakia • Pulpotomy • Pulpotomy as adjunct to root canal therapy • Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment • 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 level and tooth mobility • Laser-assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium) • Periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol

Source page: https://510kreport.com/device/K151763
Methodology: https://510kreport.com/methodology