510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Gelflex Laboratories

PERTH Western Australia, AU

GELFLEX LABORATORIES appears in FDA device records in PERTH Western Australia, AU. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Gelflex Laboratories between 1996 and 2018. The busiest year on record is 1996, with 2. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Gelflex Laboratories, by decision year
YearClearances
19962
20031
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact LensLPLSubstantially Equivalent
K030027GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%LPLSubstantially Equivalent
K962711GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENSLPLSubstantially Equivalent
K962710GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENSLPLSubstantially Equivalent

Registered establishments

FDA registered establishments for Gelflex Laboratories, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96805401000426389GELFLEX LABORATORIES52 MULGUL ROAD MALAGA, PERTH Western Australia 6090 AU2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain