S4Optik REF-K2000
S4Optik REF-K2000 is a Class I device made by Lombart Brothers, Inc., listed in FDA GUDID since 18 Oct 2025 (UDI-DI 00860014277528), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860014277528 | Date18 Oct 2025 | StatusListed |
Official records
- AccessGUDID record 00860014277528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Automated ophthalmic refractometer
- Model / reference
- REF-K2000
- Primary DI / UDI-DI
- 00860014277528
- FDA product code
- HKO
- GMDN term
- Automated ophthalmic refractometer
- Device class
- Class I
- Regulation number
- 886.1760
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HKO (Refractometer, Ophthalmic).
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- TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM by Topcon Medical Systems, Inc.
- AR-1600G AUTO-REFRACTOMETER by Nidek, Inc.
- SR-IV PROGRAMMED SUBJECTIVE REFRACTOR by American Optical Corp.
- AUTO REFF-30 by CANON INC.
- AUTO REFRACTOMETER NR-1000 by Nippon Kogaku, Inc.