# K122020: Photon Photon Plus

- Pathway: 510(k) (Traditional)
- Applicant: Zolar Technology & Mfg Co., Inc.
- Decided: Jun 5, 2013 after 330 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: 18 generations back to K943450 (1995). 191 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102359: Picasso/ Picasso Lite/ Picasso Perio, Amd Lasers, LLC (2011) Summary page 1.
- K111689: Stlase, Dental Photonics, Inc. (2012) Summary page 1.

## Most influential descendants
- K162114: Photon, Photon Plus (2016), 3 descendants of its own
- 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
The Photon is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. 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. LASER PERIODONTAL PROCEDURES: 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 The Photon Plus is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. Exposure of Unerupted teeth Excision of lesion or removal of Granulation tissue 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 LASER PERIODONTAL PROCEDURES: 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) Debridement of diseased epithelial lining TOOTH WHITENING INDICATIONS Laser assisted whitening/bleaching of teeth Light activation for bleaching materials for teeth whitening.

Source page: https://510kreport.com/device/K122020
Methodology: https://510kreport.com/methodology