Atlas FDA

System Sophi

FDA 510(k) clearance K250501 · decided 2025-11-14

Clearance details

K-number
K250501
Device name
System Sophi
Applicant
This AG
Decision
Substantially Equivalent
Date received
2025-02-20
Decision date
2025-11-14
Days to decision
267 days
Clearance type
Traditional
Product code
HQC
Device class
2
Regulation number
886.4670
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Heerbrugg, CH
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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™+ (K261264)Bausch and Lomb2026-05-15
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052)Bausch and Lomb, Incorporated2026-03-25
MICOR 700 with Auto I/A (K243395)Carl Zeiss Meditec Cataract Technology, Inc.2025-08-08
MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (K242801)Carl Zeiss Meditec Cataract Technology, Inc.2025-06-11
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (K240169)Bausch and Lomb, Incorporated2024-07-26
Faros Surgical System (K233398)Oertli Instrumente AG2024-06-27
UNITY VCS (8065000296); UNITY CS (8065000297) (K233876)Alcon Laboratories, Inc.2024-06-21
Stellaris Elite vision enhancement system (K232084)Bausch and Lomb2024-02-26
Centurion™ Vision System (Active Sentry™) (8065753057) (K233902)Alcon Laboratories, Inc.2024-01-10
QUATERA 700 (K230858)Carl Zeiss Meditec, AG2023-07-31
MICOR Lens Fragmentation System (K214028)Carl Zeiss Meditec Cataract Technology, Inc.2022-09-09
miCOR System Lens Fragmentation System (K222236)Carl Zeiss Meditec Cataract Technology, Inc.2022-08-24

Recalls involving this device

No recalls on record reference this clearance.