HQC · Product Code · Chrysalis Intelligence

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Sponsor	Clearances	Last 12 mo	Most recent
Carl Zeiss Meditec Cataract Technology, Inc.	6	0	2025-08-08
Carl Zeiss Meditec, AG	3	0	2023-07-31
Bausch and Lomb, Incorporated	2	1	2026-03-25
Bausch and Lomb	2	1	2026-05-15
Alcon Laboratories, Inc.	2	0	2024-06-21
Raico, LLC	1	0	2020-05-27
D.O.R.C. Dutch Ophthalmic Research Center (International)	1	0	2022-06-14
Johnson & Johnson Surgical Vision, Inc.	1	0	2021-03-12
This AG	1	1	2025-11-14
Oertli Instrumente AG	1	0	2024-06-27

Code	Type	Description	Confidence	Rationale
66850	CPT	—	High	Standard CPT for phacoemulsification with aspiration-irrigation

Date	K-number	Sponsor	Device
2026-05-15	K261264	Bausch and Lomb	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+
2026-03-25	K252052	Bausch and Lomb, Incorporated	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
2025-11-14	K250501	This AG	System Sophi
2025-08-08	K243395	Carl Zeiss Meditec Cataract Technology, Inc.	MICOR 700 with Auto I/A
2025-06-11	K242801	Carl Zeiss Meditec Cataract Technology, Inc.	MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
2024-07-26	K240169	Bausch and Lomb, Incorporated	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
2024-06-27	K233398	Oertli Instrumente AG	Faros Surgical System
2024-06-21	K233876	Alcon Laboratories, Inc.	UNITY VCS (8065000296); UNITY CS (8065000297)
2024-02-26	K232084	Bausch and Lomb	Stellaris Elite vision enhancement system
2024-01-10	K233902	Alcon Laboratories, Inc.	Centurion Vision System (Active Sentry) (8065753057)
2023-07-31	K230858	Carl Zeiss Meditec, AG	QUATERA 700
2022-09-09	K214028	Carl Zeiss Meditec Cataract Technology, Inc.	MICOR Lens Fragmentation System
2022-08-24	K222236	Carl Zeiss Meditec Cataract Technology, Inc.	miCOR System Lens Fragmentation System
2022-06-14	K213467	D.O.R.C. Dutch Ophthalmic Research Center (International)	EVA NEXUS Ophthalmic Surgical System
2022-04-19	K212241	Carl Zeiss Meditec, AG	QUATERA 700
2021-03-12	K203060	Johnson & Johnson Surgical Vision, Inc.	VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
2020-10-15	K200207	Carl Zeiss Meditec Cataract Technology, Inc.	xPORT S Lens Fragmentation System
2020-07-31	K200584	Carl Zeiss Meditec Cataract Technology, Inc.	xPORT 304 (miCOR) System Lens Fragmentation System
2020-06-15	K193376	Carl Zeiss Meditec, AG	Visalis V500, Visalis S500
2020-05-27	K192418	Raico, LLC	Phacoemulsification Needle (Tip) and Irrigation Sleeve

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