# K200693: K2 Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Hulaser, Inc.
- Decided: Nov 19, 2020 after 248 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: 20 generations back to K943450 (1995). 265 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K162114: Photon, Photon Plus, Zolar Technology & Mfg Co., Inc. (2016) Summary page 4.
- K093852: Ezlase 3 Laser System, Biolase Technology, Inc. (2010) Summary page 4.

## Most influential descendants
- 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
K2 mobile laser is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy Periodontal procedures: Sulcular debridement Implant procedures: Implant recovery Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty Other procedures: Gingival troughing, Hemostasis and coagulation, Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle

Source page: https://510kreport.com/device/K200693
Methodology: https://510kreport.com/methodology