Mis
510(k) K923543
Mis is a Class II device made by Ceram Optec, Inc., cleared under FDA 510(k) K923543 on 29 Mar 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)SESE | NumberK923543 | Date29 Mar 1993 | StatusActive |
Official records
- FDA 510(k) database K923543
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- Withdrawn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
- SESE Substantially Equivalent
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