# K232885: Dawn Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Decided: Feb 28, 2024 after 163 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: 25 generations back to K943450 (1995). 640 ancestors in all.
No later device cites it as a predicate yet.
0 of 641 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210367: D-Laser Blue, D-Laser 16, Guilin Woodpecker Medical Instrument Co., Ltd. (2022) Summary page 7.
- K221712: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm), Fotona D.O.O. (2022) Summary page 7.

## Indications for use
450 nm, 635 nm and 980 nm Diode Laser: • Intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: • Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: • Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. 810 nm Diode Laser in dentistry: • Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology • Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue • Gingival troughing for crown impression • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis and coagulation • Excisional and incisional biopsies • Fibroma removal • Frenectomy and frenotomy • Oral papillectomies • Soft tissue crown lengthening • Treatment of aphthous ulcers • Treatment of herpetic lesions • Periodontology; • Laser soft tissue curettage • Laser soft tissue curettage • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket • Cosmetic Dentistry; • Laser-assisted bleaching/whitening of the teeth • Light activation for bleaching materials for teeth whitening • Implant recovery 810 nm Diode Laser in therapy: • 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. 1064 nm Diode Laser in dentistry: • Excisional and incisional biopsies; • Excision and vaporization of herpes simplex I and II; • Frenectomy and frenotomy; • Gingivectomy; • Gingivoplasty; • Gingival incision and excision; • Hemostasis; • Implant recovery; • Operculectomy; • Pulpotomy and pulpotomy as an adjunct to root canal therapy; • Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; • Sulcular debridement or soft tissue curettage (removal of 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); • Treatment of aphthous ulcers and herpetic lesions

Source page: https://510kreport.com/device/K232885
Methodology: https://510kreport.com/methodology