Keeler Slit Lamp
by Keeler Ltd
510(k) K151394
Keeler Slit Lamp is a medical device (FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Keeler Ltd, cleared under FDA 510(k) K151394 on 10 Sep 2015, 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 | NumberK151394 | Date10 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K151394
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HJO
- FDA applicant
- Keeler Limited
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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