Atlas FDA

STYLES 30 & 31 POSTERIOR CHAMBER IOLS

FDA premarket approval P830040/S013 · decided 1990-06-28

Approval details

PMA number
P830040
Supplement
S013
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
STYLES 30 & 31 POSTERIOR CHAMBER IOLS
Generic name
intraocular lens
Applicant
Alcon Research, Ltd.
Date received
1989-12-29
Decision date
1990-06-28
Days to decision
181 days
Decision code
APPR
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Fort Worth, TX

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510(k) clearances by this applicant

RecordFirmDate
CENTURION Vision System (Active SentryTM) (K161794)Alcon Research, Ltd.2017-04-14
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520)Alcon Research, Ltd.2017-03-22
CONSTELLATION VISION SYSTEM (K141065)Alcon Research, Ltd.2014-08-22
WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031)Alcon Research, Ltd.2012-06-21
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977)Alcon Research, Ltd.2012-03-27
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951)Alcon Research, Ltd.2011-10-17
CLEARCUT S SAFETY KNIFE (K110166)Alcon Research, Ltd.2011-05-20
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860)Alcon Research, Ltd.2011-05-10