510(k) K252052

Device: Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
Applicant: Bausch and Lomb, Incorporated
510(k) number: K252052
Product code: HQC
Decision: Substantially Equivalent (SESE)
Decision date: 2026-03-25
Date received: 2025-07-01
Regulation: 886.4670
Classification name: Unit, Phacofragmentation
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Emily Smith
Address: 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

FDA Registration Numbers

3008692839
2085081
3002807090
3019924
8010510
3010220595
3010208880
3012132406
1722139
8030967
3004636440
3007867838
3010162782
3006695864
3010160527
1054713
3033485955
3008102042
3003398873
2028159
3013497605
3012236936
3016245399
3010291427
3005941719
1720929
2025303
3013875599
3029990829
2935428
2032098
3007007790
9681572
3014256632
1649518
1932180
3029973819
1058584
1526711
9611516
3012123033
1932402
2126666
3007648309
3015528097
3006946276
1313525
1644019
1319429
9615010
3005012805
1047843
3009026057
1036836
1920664
2529392
3010047402
2246552
3009337401
1650907
3003365815
1319660
1928237
3009732568
3007606649
1424263
3015456951
2029275
1317547
3007344957
3042928348
2523835
9681121

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HQC

510(k)	Device	Applicant	Decision date
K261264	Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+	Bausch and Lomb	2026-05-15
K250501	System Sophi	This AG	2025-11-14
K243395	MICOR 700 with Auto I/A	Carl Zeiss Meditec Cataract Technology, Inc.	2025-08-08
K242801	MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)	Carl Zeiss Meditec Cataract Technology, Inc.	2025-06-11
K240169	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)	Bausch and Lomb, Incorporated	2024-07-26
K233398	Faros Surgical System	Oertli Instrumente AG	2024-06-27
K233876	UNITY VCS (8065000296); UNITY CS (8065000297)	Alcon Laboratories, Inc.	2024-06-21
K232084	Stellaris Elite vision enhancement system	Bausch and Lomb	2024-02-26
K233902	Centurion Vision System (Active Sentry) (8065753057)	Alcon Laboratories, Inc.	2024-01-10
K230858	QUATERA 700	Carl Zeiss Meditec, AG	2023-07-31
K214028	MICOR Lens Fragmentation System	Carl Zeiss Meditec Cataract Technology, Inc.	2022-09-09
K222236	miCOR System Lens Fragmentation System	Carl Zeiss Meditec Cataract Technology, Inc.	2022-08-24
K213467	EVA NEXUS Ophthalmic Surgical System	D.O.R.C. Dutch Ophthalmic Research Center (International)	2022-06-14
K212241	QUATERA 700	Carl Zeiss Meditec, AG	2022-04-19
K203060	VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control	Johnson & Johnson Surgical Vision, Inc.	2021-03-12