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27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA

FDA 510(k) clearance K110951 · decided 2011-10-17

Clearance details

K-number
K110951
Device name
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
Applicant
Alcon Research, Ltd.
Decision
Substantially Equivalent
Date received
2011-04-04
Decision date
2011-10-17
Days to decision
196 days
Clearance type
Traditional
Product code
HQB
Device class
2
Regulation number
886.4690
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS recall (Z-0581-2026)Alcon Research LLC2025-11-21

PMA approvals by this applicant

RecordFirmDate
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117)Alcon Research, Ltd.2025-12-12
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S069)Alcon Research, Ltd.2025-10-03
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116)Alcon Research, Ltd.2025-09-18
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115)Alcon Research, Ltd.2025-08-25
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S068)Alcon Research, Ltd.2025-07-25
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111)Alcon Research, Ltd.2025-06-18
PROVSIC Ophthalmic Viscosurgical Device (P890047/S067)Alcon Research, Ltd.2025-02-26
AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113)Alcon Research, Ltd.2025-02-14