Atlas FDA

GEMINI OPHTHALMIC SURGERY SYSTEM

FDA 510(k) clearance K911808 · decided 1991-06-25

Clearance details

K-number
K911808
Device name
GEMINI OPHTHALMIC SURGERY SYSTEM
Applicant
Alcon Laboratories
Decision
Substantially Equivalent
Date received
1991-04-23
Decision date
1991-06-25
Days to decision
63 days
Clearance type
Traditional
Product code
HQC
Device class
2
Regulation number
886.4670
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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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
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Recalls involving this device

RecordFirmDate
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous P recall (Z-1940-2015)Alcon Research, Ltd.2015-06-29
Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy Syst recall (Z-1643-2009)Alcon Laboratories, Inc2009-05-26

PMA approvals by this applicant

RecordFirmDate
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D (P840064/S091)Alcon Laboratories2025-10-03
VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S090)Alcon Laboratories2025-07-25
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088)Alcon Laboratories2025-02-26
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086)Alcon Laboratories2024-08-12
PMMA Single-Piece Anterior Chamber IOL (P880087/S033)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071)Alcon Laboratories2024-06-20
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S085)Alcon Laboratories2024-06-17