SofLens (polymacon) Visibility Tinted Contact Lens

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval N16895 S099

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 add a low temperature storage symbol on the soflens 38 contact lens finished product labeling.

DeviceSofLens (polymacon) Visibility Tinted Contact Lens
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received2016-07-21
Decision Date2016-12-27
PMAN16895
SupplementS099
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547

Supplemental Filings

Supplement NumberDateSupplement Type
N16895Original Filing
S105 2022-02-18 30-day Notice
S104
S103 2020-03-20 30-day Notice
S102 2018-07-05 30-day Notice
S101 2018-05-15 30-day Notice
S100 2017-07-14 30-day Notice
S099 2016-07-21 Real-time Process
S098 2016-07-15 30-day Notice
S097 2015-08-03 30-day Notice
S096 2014-09-02 30-day Notice
S095 2014-01-03 135 Review Track For 30-day Notice
S094 2011-10-19 135 Review Track For 30-day Notice
S093 2011-02-08 30-day Notice
S092 2011-01-10 30-day Notice
S091 2008-11-12 Real-time Process
S090 2008-09-24 Real-time Process
S089 2005-10-18 Normal 180 Day Track No User Fee
S088 2001-01-09 Normal 180 Day Track
S087 1999-11-16 Normal 180 Day Track
S086 1999-10-26 30-day Notice
S085 1997-08-07 Normal 180 Day Track
S084 1996-10-01 Normal 180 Day Track
S083 1994-11-18 Normal 180 Day Track
S082 1993-08-12 Normal 180 Day Track
S081 1992-12-01 Normal 180 Day Track
S080 1991-11-18 Normal 180 Day Track
S079 1991-08-27 Normal 180 Day Track
S078
S077 1991-06-18 Normal 180 Day Track
S076 1991-06-05 Normal 180 Day Track
S075 1991-05-10 Normal 180 Day Track
S074 1991-05-02 Normal 180 Day Track
S073
S072
S071 1990-11-05 Normal 180 Day Track
S070 1990-11-05 Normal 180 Day Track
S069 1990-08-23 Normal 180 Day Track
S068 1990-07-03 Normal 180 Day Track
S067 1990-03-08 Normal 180 Day Track
S066 1989-08-29 Normal 180 Day Track
S065
S064 1989-08-28 Normal 180 Day Track
S063 1989-07-24 Normal 180 Day Track
S062 1989-07-24 Normal 180 Day Track
S061 1989-07-21 Normal 180 Day Track
S060 1989-05-25 Normal 180 Day Track
S059 1989-01-03 Normal 180 Day Track
S058 1988-12-09 Normal 180 Day Track
S057 1988-12-09 Normal 180 Day Track
S056 1988-12-08 Normal 180 Day Track
S055 1988-12-06 Normal 180 Day Track
S054 1988-09-20 Normal 180 Day Track
S053 1988-08-05 Special (immediate Track)
S052 1988-07-29 Normal 180 Day Track
S051 1987-10-15 Normal 180 Day Track
S050 1987-09-02 Normal 180 Day Track
S049 1987-08-06 30-Day Supplement
S048 1987-05-15 Normal 180 Day Track
S047 1987-02-02 30-Day Supplement
S046 1987-01-21 Normal 180 Day Track
S045 1987-01-05 Normal 180 Day Track
S044 1986-08-20 Normal 180 Day Track
S043 1986-04-22
S042 1986-03-18 Normal 180 Day Track
S041 1986-03-18
S040 1985-08-30
S039
S038 1985-03-20
S037 1985-02-07
S036 1984-07-23
S035
S034
S033 1984-06-22
S032
S031 1984-05-08
S030
S029 1983-11-14
S028 1983-04-13
S027 1982-12-27
S026 1982-12-16
S025 1982-08-25
S024 1982-07-20
S023 1982-05-20
S022
S021 1982-02-19
S020 1981-12-17
S019 1981-10-19
S018 1981-07-29
S017 1981-05-05
S016
S015 1980-12-30
S014 1980-09-26
S013 1980-08-25
S012 1980-08-25
S011 1980-08-15
S010 1980-08-01
S009 1980-05-05
S008 1980-04-21
S007 1980-02-05
S006 1979-08-02
S005 1979-07-13
S004 1979-06-06
S003 1979-02-15
S002 1978-12-11
S001 1979-03-02 Normal 180 Day Track

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