Atlas FDA

FLEXLENS

FDA premarket approval N17976/S008 · decided 1990-01-16

Approval details

PMA number
N17976
Supplement
S008
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
FLEXLENS
Generic name
Lenses, soft contact, daily wear
Applicant
Paragon Vision Sciences
Date received
1989-06-16
Decision date
1990-01-16
Days to decision
214 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Mesa, AZ

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510(k) clearances by this applicant

RecordFirmDate
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG (K180172)Paragon Vision Sciences2018-03-16
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN (K120996)Paragon Vision Sciences2012-06-28
HDS HI 1.54 (K082799)Paragon Vision Sciences2009-01-27
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES (K070637)Paragon Vision Sciences2007-05-01
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES (K052983)Paragon Vision Sciences2006-02-10
PVS BASIC 2; EPIC 2 (K013310)Paragon Vision Sciences2002-04-25
FLUOROPERM 151-OK, PARAGON HDS 100-OK (K010109)Paragon Vision Sciences2001-02-28
PAFLUFOCON C AND E DAILY CONTACT LENS (K002845)Paragon Vision Sciences2000-12-08