Submission Details
| 510(k) Number | K993357 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 06, 1999 |
| Decision Date | March 20, 2000 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
IOLMASTER
Mar 2000
Decision
166d
Days
Class 2
Risk
About This 510(k) Submission
K993357 is an FDA 510(k) clearance for the IOLMASTER, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on March 20, 2000, 166 days after receiving the submission on October 6, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.
Device Classification
| Product Code | HJO — Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1850 |
Manufacturer
Similar Devices — HJO Biomicroscope, Slit-lamp, Ac-powered
All 106
K231760 · Cylite Pty. , Ltd.
· Mar 2024
K222372 · Kowa Company , Ltd.
· Nov 2022
K193188 · Medimaging Integrated Solution, Inc (Miis)
· Jan 2020
K182306 · Chongqing Sunkingdom Medical Instrument Co., Ltd.
· Nov 2018
K173771 · Carl Zeiss Meditec, AG
· Aug 2018
K171877 · Chongqing Kanghua Ruiming S&T Co., Ltd.
· Dec 2017
More from Carl Zeiss, Inc.
View all
K013402
· GEX · Nov 2001
K003885
· GEX · Feb 2001
K983868
· GEX · Jan 1999
K965139
· HAW · Apr 1997
K961380
· GEX · Mar 1997