# K162114: Photon, Photon Plus

- Pathway: 510(k) (Traditional)
- Applicant: Zolar Technology & Mfg Co., Inc.
- Decided: Dec 12, 2016 after 136 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). 264 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121286: EPIC 10, Biolase Technology, Inc. (2012) Summary page 9.
- K123443: Precise SHP Diode Laser, CAO Group, Inc. (2013) Summary page 9.
- K122020: Photon Photon Plus, Zolar Technology & Mfg Co., Inc. (2013) Summary page 7.

## Most influential descendants
- K200693: K2 Mobile (2020), 2 descendants of its own
- K261047: Dental Diode Laser Device (Laser-Pen) (2026), 0 descendants of its own
- K201387: Ultrafast, Ultrafast Plus, Ultrafast Lite (2021), 0 descendants of its own

## Indications for use
1. DENTAL SOFT TISSUE INDICATIONS The indications are identical to the previously cleared predicate systems. Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications: * Exposure of Unerupted teeth + Fibroma removal * Frenectomy « Gingival Troughing for crown impressions * Gingivectomy * Gingivoplasty » Hemostasis and coagulation « Gingival incision and excision hemostasis Implant recovery » Incision and drainage of abscess * Leukoplakia *» Operculectomy * Oral papillectomies * Pulpotomy as an adjunct to root canal therapy * Reduction of gingival hypertrophy « Soft tissue crown lengthening « Gingival bleeding index » Excisional and incisional biopsies » Treatment of aphthous ulcer canker sores and herpetic. * Vestibuloplasty 2. LASER PERIODONTAL INDICATIONS: « Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility) « Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. 3. TOOTH WHITENING INDICATIONS » Laser Assisted whitening/bleaching of teeth. » Light activation for bleaching materials for teeth whitening. 4. PAIN INDICATIONS: » Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis 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/K162114
Methodology: https://510kreport.com/methodology