Dental Diode Laser System
by Lazon Medical Laser Co., Ltd.
510(k) K180967
Dental Diode Laser System is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lazon Medical Laser Co., Ltd., cleared under FDA 510(k) K180967 on 11 Jul 2018 and listed in FDA GUDID since 8 Jan 2019 (UDI-DI 06970750060040), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06970750060040 | Date8 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK180967 | Date11 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 06970750060040
- FDA 510(k) database K180967
Across registries
- FDA 510(k) K180967 decided 11 Jul 2018 Active
- FDA GUDID UDI-DI 06970750060040 listed 8 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K180967
- Listed FDA GUDID 06970750060040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental diode laser system
- Model / Ref / Catalog
- SOLASE-808, 04
- Primary DI / UDI-DI
- 06970750060040
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dental diode laser system
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Devices cleared under K180967
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Dental Diode Laser System SOLASE-808 | 01 / SOLASE-808 | 06970750060019 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 02 / SOLASE-808 | 06970750060026 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 03 / SOLASE-808 | 06970750060033 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 04 / SOLASE-808 | 06970750060040 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 05 / SOLASE-808 | 06970750060057 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 06 / SOLASE-808 | 06970750060064 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 07 / SOLASE-808 | 06970750060071 | — | On the market |
| Dental Diode Laser System SOLASE-808 | 08 / SOLASE-808 | 06970750060088 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 01 / SOLASE-976 | 06970750060095 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 02 / SOLASE-976 | 06970750060101 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 03 / SOLASE-976 | 06970750060118 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 04 / SOLASE-976 | 06970750060125 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 05 / SOLASE-976 | 06970750060132 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 06 / SOLASE-976 | 06970750060149 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 07 / SOLASE-976 | 06970750060156 | — | On the market |
| Dental Diode Laser System SOLASE-976 | 08 / SOLASE-976 | 06970750060163 | — | On the market |
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
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- DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE by Dornier MedTech America, Inc.
- ADD'L USE OF THE KTP/YAG SURGICAL LASER by Laserscope
- CB DIODE/532 LASER SYSTEM by Continuum Biomedical, Inc.
- Rapid Acoustic Pulse Device by Soliton, Inc.
- STLASE DIODE LASER by Dental Photonics, Inc.