NVK · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2021-02-26 → 2026-05-19

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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

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

NVK · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances