510(k) K232084

Device: Stellaris Elite vision enhancement system
Applicant: Bausch and Lomb
510(k) number: K232084
Product code: HQC
Decision: Substantially Equivalent (SESE)
Decision date: 2024-02-26
Date received: 2023-07-13
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: No

Related Records

Applicant Contact

Contact: Rekha Janarthanan
Address: 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

FDA Registration Numbers

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

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
K252052	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)	Bausch and Lomb, Incorporated	2026-03-25
K250501	System Sophi	This AG	2025-11-14
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K240169	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)	Bausch and Lomb, Incorporated	2024-07-26
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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
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