# K253309: SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Soga Technology Co., Ltd.
- Decided: May 19, 2026 after 232 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). 602 ancestors in all.
No later device cites it as a predicate yet.
0 of 603 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242202: LightWalker Laser System Family, Fotona D.O.O. (2024) Summary page 6.
- K210367: D-Laser Blue, D-Laser 16, Guilin Woodpecker Medical Instrument Co., Ltd. (2022) Summary page 6.

## Indications for use
Aurora-S: • Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); • Leukoplakia; • Pulpotomy as adjunct to root canal retreatment; • Pulp extirpation; • Removal of fibromae; • Removal of granulated tissue; • Caries removal, cavity preparation, enamel roughening; • Sulcular debridement; • Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement; • Cutting, shaving, contouring and resection of oral osseous tissue (bone); • Osteotomy, osseous crown lengthening, osteoplasty; • Apicectomy surgery; • Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage; • Laser removal of porcelain and ceramic crowns and veneers; • Flap preparation – incision of soft-tissue to prepare a flap and expose the bone; • Cutting bone to prepare a window access to the apex (apices) of the root(s); • Root-end preparation for retrofill amalgam or composite; • Full thickness flap; • Partial thickness flap; • Split thickness flap; • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium; • Excisional and incisional biopsies; • Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); • Frenectomy and frenotomy; • Gingival troughing for crown impressions; • Gingivectomy; • Gingivoplasty; • Implant recovery; • Root canal debridement and cleaning; • Soft tissue crown lengthening; • Laser root canal disinfection after endodontic treatment ILaser III Pro: SOGA Lasers therapy system family of the Dental diode laser is intended for intra-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 sulcus periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; herpetic ulcers of the oral mucosa; laser soft tissue curettage.

Source page: https://510kreport.com/device/K253309
Methodology: https://510kreport.com/methodology