Oneuse- Plus Microkeratome
by Moria SA
510(k) K040297
Oneuse- Plus Microkeratome is a medical device (FDA Class I; FDA product code HMY, Keratome, Battery-Powered) made by Moria SA, cleared under FDA 510(k) K040297 on 31 Mar 2004, 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 | NumberK040297 | Date31 Mar 2004 | StatusActive |
Official records
- FDA 510(k) database K040297
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HMY
- Device class
- Class I
- Regulation
- 21 CFR Part 886.4370
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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