Med-Logics, Model ML7090
510(k) K033293
Med-Logics, Model ML7090 is a medical device (FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Med Logics Inc, cleared under FDA 510(k) K033293 on 13 Jan 2004, active as of 9 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033293 | Date13 Jan 2004 | StatusActive |
Official records
- FDA 510(k) database K033293
Recalls
-
- Terminated Z-1268-2015
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Timeline
- Cleared FDA 510(k) K033293
- Recall initiated FDA recalls Z-1268-2015
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- Withdrawn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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