De Luxe
by Rudolf Riester GmbH & Co. KG
510(k) K925755
De Luxe is a Class II device made by Rudolf Riester GmbH & Co. KG, cleared under FDA 510(k) K925755 on 3 Dec 1993, 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 | FDA 510(k)SESK | NumberK925755 | Date3 Dec 1993 | StatusActive |
Official records
- FDA 510(k) database K925755
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HLJ
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1570
- Advisory committee
- Ophthalmic
- FDA decision
- SESK Substantially Equivalent — Kit
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