510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Unicon Optical Co., Ltd.

Hsinchu County, TW

UNICON OPTICAL CO., LTD. appears in FDA device records in Hsinchu County, TW. FDA records list 5 510(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
5
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Unicon Optical Co., Ltd. between 2014 and 2024. The busiest year on record is 2019, with 2. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Unicon Optical Co., Ltd., by decision year
YearClearances
20141
20192
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™LPLSubstantially Equivalent
K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensLPLSubstantially Equivalent
K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensLPLSubstantially Equivalent
K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable ContacLPLSubstantially Equivalent
K141917UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEARLPLSubstantially Equivalent

Registered establishments

FDA registered establishments for Unicon Optical Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30131700703013170070UNICON OPTICAL CO., LTD.No.16, Gongye E. 9th Rd., Hsinchu County Hsinchu(County) 30075 TW2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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