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

SUNGAI BULOH Selangor, MY

SUPERVISION OPTIMAX SDN BHD appears in FDA device records in SUNGAI BULOH Selangor, MY. FDA records list 2 510(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
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Supervision Optimax Sdn Bhd between 2017 and 2018. The busiest year on record is 2017, with 1. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Supervision Optimax Sdn Bhd, by decision year
YearClearances
20171
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesLPLSubstantially Equivalent
K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)LPLSubstantially Equivalent

Registered establishments

FDA registered establishments for Supervision Optimax Sdn Bhd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30135765283013576528SUPERVISION OPTIMAX SDN BHDLOT 38, PUTRA INDUSTRIAL PARK, SUNGAI BULOH Selangor 40160 MY2026

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