ProFlex DSU273PT
ProFlex DSU273PT is a Class II device made by Innovaquartz LLC, cleared under FDA 510(k) K142638 on 19 Dec 2014 and listed in FDA GUDID since 1 Mar 2017 (UDI-DI 00816959020828), 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 | Number00816959020828 | Date1 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142638 | Date19 Dec 2014 | StatusActive |
Official records
- AccessGUDID record 00816959020828
- FDA 510(k) database K142638
Across registries
- FDA 510(k) K142638 decided 19 Dec 2014 Active
- FDA GUDID UDI-DI 00816959020828 listed 1 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K142638
- Listed FDA GUDID 00816959020828
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProFlex
- Generic name
- General/multiple surgical laser system beam guide, reusable
- Model / Ref / Catalog
- DSU273PT
- Primary DI / UDI-DI
- 00816959020828
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical laser system beam guide, reusable
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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