Apolomed HS-232
by Shanghai Apolo Medical Technology Co., Ltd
Apolomed HS-232 is a dermatological dye laser system (FDA Class II; FDA product code ONG, Powered Laser Surgical Instrument With Microbeam\Fractional Output) made by Shanghai Apolo Medical Technology Co., Ltd, cleared under FDA 510(k) K251031 on 2 Jul 2025 and listed in FDA GUDID since 21 Jul 2025 (UDI-DI 06970745912323), 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 | Number06970745912323 | Date21 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK251031 | Date2 Jul 2025 | StatusActive |
Official records
- AccessGUDID record 06970745912323
- FDA 510(k) database K251031
Across registries
- FDA 510(k) K251031 decided 2 Jul 2025 Active
- FDA GUDID UDI-DI 06970745912323 listed 21 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K251031
- Listed FDA GUDID 06970745912323
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Apolomed
- Generic name
- Dermatological dye laser system
- Model / reference
- HS-232
- Primary DI / UDI-DI
- 06970745912323
- 510(k) Number
- FDA product code
- ONG
- GMDN term
- Dermatological dye laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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