510(k) K230047
- Device
- Medical Diode Laser Systems
- Applicant
- Gigaalaser Company , Ltd.
- 510(k) number
- K230047
- Product code
- NVK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-04
- Date received
- 2023-01-06
- Regulation
- 878.4810
- Classification name
- Laser, Dental, Soft Tissue
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Xinxing Nie
- Address
- 304, 306, 3f #3 Plant, Bldg. B10 Wuhan Hi-Tech Medical Device Industrial Park Wuhan CN 430206 430206
FDA Registration Numbers
- 1000548922
- 1032227
- 2916735
- 1419489
- 3004505220
- 3005515469
- 3011877721
- 3005972890
- 3030090167
- 3017125161
- 3001431138
- 3005581016
- 3017181358
- 3018318562
- 2027755
- 3004475754
- 9613462
- 1725006
- 3010175098
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06977331780007 | GIGAA | Gigaalaser Company Ltd. | 2024-11-30 |
| 06977331780038 | GIGAA | Gigaalaser Company Ltd. | 2024-11-01 |
| 06977331780021 | GIGAA | Gigaalaser Company Ltd. | 2024-11-01 |
| 06977331780014 | GIGAA | Gigaalaser Company Ltd. | 2024-11-01 |
Other 510(k) Records For Product Code NVK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | Shenzhen Soga Technology Co., Ltd. | 2026-05-19 |
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | 2026-03-10 |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | 2025-10-16 |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. | 2025-05-08 |
| K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-02-28 |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency S.R.L. | 2023-11-27 |
| K221761 | Solea | Convergent Dental, Inc. | 2022-09-14 |
| K211150 | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | 2022-07-01 |
| K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | 2022-05-10 |
| K213658 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | 2022-03-11 |
| K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-03-10 |
| K213428 | EdgePro | Biolase, Inc. | 2021-12-22 |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021-11-18 |
| K203396 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | 2021-08-23 |
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | 2021-02-26 |