# K152032: ELUMI 810 + 980 Soft Tissue Laser

- Pathway: 510(k) (Traditional)
- Applicant: Azena Medical, LLC
- Decided: Sep 16, 2015 after 56 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: 7 generations back to K922901 (1992). 25 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W, Quicklase Limited (2010) Summary page 6.

## Most influential descendants
- K193486: Epic 980 (2020), 2 descendants of its own
- K192617: Gemini 810+980 Soft Tissue Laser (2020), 2 descendants of its own
- K234085: LUNE™ PureHygiene (2024), 1 descendant of its own
- K210350: Gemini 2 810+980 Soft Tissue Laser (2021), 1 descendant of its own
- K260138: LUNE PureHygiene (2026), 0 descendants of its own

## Indications for use
The indications for use are identical to those of the previously cleared Predicate Device. The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue. The following are the oropharyngeal indications for use: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Gingivoplasty • Hemostasis and coagulation • Incision and drainage of abscess • Operculectomy • Pulpotomy • Reduction of gingival hypertrophy • Soft tissue crown lengthening • Vestibuloplasty • Laser Soft Tissue Curettage • Tissue retraction • Frenectomy and Frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingival incision and excision • Implant recovery • Leukoplakia • Oral papillectomnies • Pulpotomy as an adjunct to root canal therapy • Reduction of bacterial level (decontamination) and inflammation • Treatment of aphthous ulcers • Lesion (tumor) removal • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Removal of Diseased, Infected, Inflamed and necrotic soft tissue within the periodontal pocket • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium • Sulcular debridement (removal of necrotic, 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) • Light activation for bleaching materials for teeth whitening • Laser-assisted whitening/bleaching of teeth

Source page: https://510kreport.com/device/K152032
Methodology: https://510kreport.com/methodology