Confoscan
510(k) K971953
Confoscan is a medical device (FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Tomey Corporation USA, cleared under FDA 510(k) K971953 on 14 Aug 1997, 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 | NumberK971953 | Date14 Aug 1997 | StatusActive |
Official records
- FDA 510(k) database K971953
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HJO
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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