Ml Microkeratome
510(k) K981071
Ml Microkeratome is a medical device (FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Med Logics Inc, cleared under FDA 510(k) K981071 on 23 Jul 1998, active as of 11 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 | NumberK981071 | Date23 Jul 1998 | StatusActive |
Official records
- FDA 510(k) database K981071
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HNO
- FDA applicant
- Med-Logics, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 886.4370
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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- MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME by Ciba Vision Corporation
- MICROKERATOME OR THE MATE by Howard Instruments, Inc.
- Treatment Packs (Size M) 1462-333 by Carl Zeiss Meditec AG