# K232222: Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

- Pathway: 510(k) (Traditional)
- Applicant: Medency S.R.L.
- Decided: Nov 27, 2023 after 124 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: 20 generations back to K943450 (1995). 254 ancestors in all.
No later device cites it as a predicate yet.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192430: Epic 980, Biolase, Inc. (2019) Summary page 8.
- K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W, Quicklase Limited (2010) Summary page 8.
- K180044: SIROLaser Blue, Dentsply Sirona (2018) Summary page 8.
- K172771: Epic Pro 940, Biolase, Inc. (2017) Summary page 8.
- K152032: ELUMI 810 + 980 Soft Tissue Laser, Azena Medical, LLC (2015) Summary page 8.

## Indications for use
1. Dental Soft Tissue Indications incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications: - Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Frenectomy - Frenotomy - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis and coagulation - Implant recovery - Incision and drainage of abscess - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy - Pulpotomy as an adjunction to root canal therapy - Reduction of gingival hypertrophy - Soft-tissue crown lengthening - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty - Tissue retraction for impression - Reduction of bacterial level (decontamination) and inflammation 2. Laser Periodontal Procedures - Laser soft-tissue curettage - Laser removal of diseased, infected, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). 3. Whitening - Light activation for bleaching materials for teeth whitening - Laser-assisted whitening/bleaching of teeth 4. Pain Therapy - Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K232222
Methodology: https://510kreport.com/methodology