Anterior Eye-Segment Analysis System
by Nidek, Inc.
510(k) K991284
Anterior Eye-Segment Analysis System is a medical device (FDA Class II; FDA product code MXK, Device, Analysis, Anterior Segment) made by Nidek, Inc., cleared under FDA 510(k) K991284 on 6 Aug 1999, active as of 12 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 | NumberK991284 | Date6 Aug 1999 | StatusActive |
Official records
- FDA 510(k) database K991284
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MXK
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MXK (Device, Analysis, Anterior Segment).
- VISIONIX VX120 by LUNEAU TECHNOLOGY OPERATIONS
- Pentacam Scheimpflug Camera by OCULUS Optikgeräte GmbH
- BOSS by Intelon Optics, Inc.
- VISIONIX VX130+ by LUNEAU TECHNOLOGY OPERATIONS
- OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER by Haag-Streit Holding AG
- Tomey Optical Biometer OA-2000 (OA-2000) by TOMEY CORPORATION
- NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) by Bausch & Lomb, Inc.
- Galilei G6 Lens Professional by SIS AG, Surgical Instrument Systems
- Pentacam® Cornea OCT by OCULUS Optikgeräte GmbH
- CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA by SIS AG, Surgical Instrument Systems