Atlas FDA

BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS

FDA premarket approval P860022/S034 · decided 1991-04-05

Approval details

PMA number
P860022
Supplement
S034
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS
Generic name
Lens, contact (other material) - daily
Applicant
Bausch & Lomb
Date received
1991-03-20
Decision date
1991-04-05
Days to decision
16 days
Decision code
APPR
Product code
HQD
Advisory committee
Ophthalmic
Expedited review
No
Location
Rochester, NY

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510(k) clearances by this applicant

RecordFirmDate
Stellaris Elite vision enhancement system (K170052)Bausch+Lomb2017-04-19
Stellaris Elite Vision Enhancement System (K162342)Bausch+Lomb2017-03-24
STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486)Bausch & Lomb2014-03-12
STELLARIS VISION ENHANCEMENT SYSTEM (K133242)Bausch & Lomb2014-02-14
BAUSCH & LOMB INJECTOR SYSTEM (K131958)Bausch & Lomb2014-01-09
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146)Bausch & Lomb2014-01-03
EASY-LOAD LENS DELIVERY SYSTEM (K132481)Bausch & Lomb2013-12-27
CRYSTALSERT DELIVERY SYSTEM (K132593)Bausch & Lomb2013-09-17