Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment

Lens, Contact, Orthokeratology, Overnight

FDA Premarket Approval P010062 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to update the contact lens labeling to remove references to a tap water rinse and replace with a saline rinse, and update warnings related to use of water

DeviceBoston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment
Classification NameLens, Contact, Orthokeratology, Overnight
Generic NameLens, Contact, Orthokeratology, Overnight
ApplicantBAUSCH & LOMB
Date Received2018-05-25
Decision Date2018-07-19
PMAP010062
SupplementS011
Product CodeNUU
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BAUSCH & LOMB 1400 North Goodman St. rochester, NY 14603-0450

Supplemental Filings

Supplement NumberDateSupplement Type
P010062Original Filing
S011 2018-05-25 Real-time Process
S010 2016-06-27 30-day Notice
S009 2011-05-31 30-day Notice
S008 2010-10-20 Normal 180 Day Track No User Fee
S007 2009-10-13 Normal 180 Day Track No User Fee
S006 2008-01-31 Real-time Process
S005 2006-12-21 Real-time Process
S004 2006-01-27 135 Review Track For 30-day Notice
S003 2005-04-18 Normal 180 Day Track No User Fee
S002 2004-09-01 Real-time Process
S001 2004-07-06 Real-time Process

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