510(k) K210367
- Device
- D-Laser Blue, D-Laser 16
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
- 510(k) number
- K210367
- Product code
- NVK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-10
- Date received
- 2021-02-08
- Regulation
- 878.4810
- Classification name
- Laser, Dental, Soft Tissue
- Medical specialty
- General & Plastic Surgery
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yang Yunfeng
- Address
- Information Industrial Park Guilin National High-Tech Zone Guilin CN 541004 541004
FDA Registration Numbers#
- 3010175098
- 3004475754
- 3018318562
- 3005515469
- 9613462
- 1000548922
- 3004505220
- 2027755
- 1419489
- 3017181358
- 3005581016
- 1032227
- 3011877721
- 3017125161
- 1725006
- 3030090167
- 2916735
- 3001431138
- 3005972890
Source Documents#
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 |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | 2024-03-04 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases