Submission Details
| 510(k) Number | K101325 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2010 |
| Decision Date | August 17, 2010 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
STELLARIS PC VISION ENHANCEMENT SYSTEM
Aug 2010
Decision
97d
Days
Class 2
Risk
About This 510(k) Submission
K101325 is an FDA 510(k) clearance for the STELLARIS PC VISION ENHANCEMENT SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on August 17, 2010, 97 days after receiving the submission on May 12, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.
Device Classification
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |
Manufacturer
Similar Devices — HQC Unit, Phacofragmentation
All 313
K250501 · This AG
· Nov 2025
K243395 · Carl Zeiss Meditec Cataract Technology, Inc.
· Aug 2025
K242801 · Carl Zeiss Meditec Cataract Technology, Inc.
· Jun 2025
K240169 · Bausch and Lomb, Incorporated
· Jul 2024
K233398 · Oertli Instrumente AG
· Jun 2024
K233876 · Alcon Laboratories, Inc.
· Jun 2024
More from Bausch & Lomb, Inc.
View all
K192005
· MSS · Oct 2019
K173480
· MSS · Dec 2017
K151102
· MSS · May 2015
K131208
· LPL · Sep 2013
K122575
· LPL · Dec 2012