Ml Microkeratome Blade
510(k) K962661
Ml Microkeratome Blade is a medical device (FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Med Logics Inc, cleared under FDA 510(k) K962661 on 9 Dec 1996, active as of 10 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 | NumberK962661 | Date9 Dec 1996 | StatusActive |
Official records
- FDA 510(k) database K962661
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- Withdrawn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
Devices cleared under K962661
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ML7003 | ML7003 / ML7003 | 00850724001018 | — | On the market |
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