NVK · Laser, Dental, Soft Tissue · Chrysalis Intelligence

Device class

Class II

Regulation 878.4810

Total clearances

2021-02-26 → 2026-05-19

Last 12 months

Unique sponsors

Definition

What is Laser, Dental, Soft Tissue

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4810

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Shenzhen Soga Technology Co., Ltd.	3	1	2026-05-19
El.En Electronic Engineering Spa	2	0	2022-03-11
Azena Medical, LLC	2	1	2026-03-10
Convergent Dental, Inc.	1	0	2022-09-14
Biolase, Inc.	1	0	2021-12-22
Guilin Woodpecker Medical Instrument Co., Ltd.	1	0	2022-03-10
Matelaser, Inc.	1	1	2025-10-16
Dentlight, Inc.	1	0	2021-02-26
Medency S.R.L.	1	0	2023-11-27
Wuhan Pioon Technology Co., Ltd.	1	0	2025-05-08
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd	1	0	2024-02-28
Gigaalaser Company , Ltd.	1	0	2024-03-04

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
D5992	CPT	—	High	ADA CDT code for intraoral laser soft tissue surgery (dentistry-specific)
41512	CPT	—	Medium	CPT code for excision of lesion of tongue, soft tissue surgery using laser technology

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-19	K253309	Shenzhen Soga Technology Co., Ltd.	SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
2026-03-10	K260765	Azena Medical, LLC	Gemini NOVA 810+980 Soft Tissue Laser
2025-10-16	K250731	Matelaser, Inc.	MateLaser Medical Diode Laser Systems (ML-DLS-30)
2025-05-08	K243764	Wuhan Pioon Technology Co., Ltd.	Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
2024-03-04	K230047	Gigaalaser Company , Ltd.	Medical Diode Laser Systems
2024-02-28	K232885	Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd	Dawn Diode Laser System
2023-11-27	K232222	Medency S.R.L.	Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
2022-09-14	K221761	Convergent Dental, Inc.	Solea
2022-07-01	K211150	Shenzhen Soga Technology Co., Ltd.	Dental diode laser, SOGA Laser, ILaser II
2022-05-10	K214008	Shenzhen Soga Technology Co., Ltd.	Dental diode laser
2022-03-11	K213658	El.En Electronic Engineering Spa	DEKA SMARTPERIO
2022-03-10	K210367	Guilin Woodpecker Medical Instrument Co., Ltd.	D-Laser Blue, D-Laser 16
2021-12-22	K213428	Biolase, Inc.	EdgePro
2021-11-18	K210350	Azena Medical, LLC	Gemini 2 810+980 Soft Tissue Laser
2021-08-23	K203396	El.En Electronic Engineering Spa	DEKA SMARTPERIO
2021-02-26	K201387	Dentlight, Inc.	Ultrafast, Ultrafast Plus, Ultrafast Lite