Ar-1600 Automatic Refractor
by Nidek, Inc.
510(k) K861062
Ar-1600 Automatic Refractor is a medical device (FDA Class I; FDA product code HKO, Refractometer, Ophthalmic) made by Nidek, Inc., cleared under FDA 510(k) K861062 on 4 Apr 1986, 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 | NumberK861062 | Date4 Apr 1986 | StatusActive |
Official records
- FDA 510(k) database K861062
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HKO
- Device class
- Class I
- Regulation
- 21 CFR Part 886.1760
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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