GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K030027
Device Name GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
Original Applicant
GELFLEX LABORATORIES
3 hutton st., osborne park
perth, western, wa, 

AU

6017

Original Contact peter g bryant
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 01/03/2003
Decision Date 04/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No