Stellaris Elite vision enhancement system
FDA 510(k) K232084 · Bausch and Lomb
510(k) numberK232084
Submission
- Device name
- Stellaris Elite vision enhancement system
- Applicant
- Bausch and Lomb
St. Louis, MO, US - Received
- July 13, 2023
- Decision date
- February 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | Alcon Laboratories, Inc. | 01/10/2024SE |
| K230858 | Quatera 700HQC · Traditional | Carl Zeiss Meditec, AG | 07/31/2023SE |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special | 05/15/2026SE |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional | 03/25/2026SE |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional | 07/26/2024SE |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionMRC · Traditional | 03/27/2018SE |
| K161012 | Easy-Load Lens Delivery SystemMSS · Special | 07/06/2016SE |
Questions and answers
When was Stellaris Elite vision enhancement system cleared by the FDA?
Stellaris Elite vision enhancement system (K232084) received a 510(k) decision of Substantially Equivalent on February 26, 2024, 228 days after the submission was received.
What is the product code of K232084?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.