Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
FDA 510(k) K252052 · Bausch and Lomb, Incorporated
510(k) numberK252052
Submission
- Device name
- Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- Applicant
- Bausch and Lomb, Incorporated
St. Louis, MO, US - Received
- July 1, 2025
- Decision date
- March 25, 2026
- 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 |
| 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 |
| 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 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional | 07/26/2024SE |
| K232084 | Stellaris Elite vision enhancement systemHQC · Traditional | 02/26/2024SE |
| 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 (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) cleared by the FDA?
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052) received a 510(k) decision of Substantially Equivalent on March 25, 2026, 267 days after the submission was received.
What is the product code of K252052?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.