Stellaris PC Vision Enhancement System
FDA 510(k) K101325 · Bausch & Lomb, Inc.
510(k) numberK101325
Submission
- Device name
- Stellaris PC Vision Enhancement System
- Applicant
- Bausch & Lomb, Inc.
Rochester, NY, US - Received
- May 12, 2010
- Decision date
- August 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
Other 510(k)s with product code HQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special | Bausch and Lomb | 05/15/2026SE |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional | Bausch and Lomb, Incorporated | 03/25/2026SE |
| K250501 | System SophiHQC · Traditional | This AG | 11/14/2025SE |
| K243395 | MICOR 700 with Auto I/AHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 08/08/2025SE |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 06/11/2025SE |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional | Bausch and Lomb, Incorporated | 07/26/2024SE |
| K233398 | Faros Surgical SystemHQC · Traditional | Oertli Instrumente AG | 06/27/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | Alcon Laboratories, Inc. | 06/21/2024SE |
| K232084 | Stellaris Elite vision enhancement systemHQC · Traditional | Bausch and Lomb | 02/26/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | Alcon Laboratories, Inc. | 01/10/2024SE |
More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242389 | EyeGility Inserter for Preloaded enVista IOLsMSS · Traditional | 10/10/2024SE |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…LPL · Traditional | 03/08/2023SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | 12/06/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | 05/28/2021SE |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaLPL · Traditional | 05/24/2021SE |
| K200416 | Boston One Step Liquid Enzymatic CleanerMRC · Traditional | 09/23/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | 10/04/2019SE |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…HQD · Traditional | 02/12/2019SE |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL · Traditional | 11/30/2018SE |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…MRC · Traditional | 08/10/2018SE |
Questions and answers
When was Stellaris PC Vision Enhancement System cleared by the FDA?
Stellaris PC Vision Enhancement System (K101325) received a 510(k) decision of Substantially Equivalent on August 17, 2010, 97 days after the submission was received.
What is the product code of K101325?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.