Globalipl US419
by Beijing Globalipl Development Co., Ltd.
Globalipl US419 is a multi-modality skin surface treatment system (FDA Class II) made by Beijing Globalipl Development Co., Ltd., cleared under FDA 510(k) K193328 on 25 Mar 2020 and listed in FDA GUDID since 29 Jun 2020 (UDI-DI 06973494934196), 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 | Number06973494934196 | Date29 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193328 | Date25 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 06973494934196
- FDA 510(k) database K193328
Across registries
- FDA 510(k) K193328 decided 25 Mar 2020 Active
- FDA GUDID UDI-DI 06973494934196 listed 29 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K193328
- Listed FDA GUDID 06973494934196
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Globalipl
- Generic name
- Multi-modality skin surface treatment system
- Model / reference
- US419
- Primary DI / UDI-DI
- 06973494934196
- 510(k) Number
- FDA product code
- ONF, GEX
- GMDN term
- Multi-modality skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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