Auto Refractometer
by Nidek, Inc.
510(k) K831083
Auto Refractometer is a Class I device made by Nidek, Inc., cleared under FDA 510(k) K831083 on 10 Jun 1983, 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 | NumberK831083 | Date10 Jun 1983 | StatusActive |
Official records
- FDA 510(k) database K831083
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- Withdrawn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
Similar devices
Other devices filed under FDA product code HKO (Refractometer, Ophthalmic).
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- I.V.E. REFRACTION SYSTEM by Bausch & Lomb, Inc.
- WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 by Visx, Incorporated