# K161185: LUCERNA Dental Laser

- Pathway: 510(k) (Traditional)
- Applicant: Viax Dental Lab
- Decided: Sep 26, 2016 after 152 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: 19 generations back to K943450 (1995). 374 ancestors in all.
No later device cites it as a predicate yet.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140120: EPIC 10, Biolase, Inc. (2014) Summary page 7.
- K930210: ACL-5500, Ilt Systems, Inc. (1993) Summary page 7.
- K103667: Sapphire ST Portable Diode Laser, Den-Mat Holdings, LLC (2010) Summary page 7.

## Indications for use
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications 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 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 . Photo initiation of gingival barriers and dams . Laser-assisted bleaching/whitening of teeth

Source page: https://510kreport.com/device/K161185
Methodology: https://510kreport.com/methodology