Data / Medical devices / Malaysia / Supervision Optimax Sdn Bhd
Supervision Optimax Sdn Bhd: FDA-registered device maker in SUNGAI BULOH Selangor, Malaysia, 2 510(k) clearances
Supervision Optimax Sdn Bhd is registered with the FDA (registration 3013576528) in SUNGAI BULOH Selangor, Malaysia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013576528
- Address
- Lot 38, Putra Industrial Park Bukit Rahman Putra, SUNGAI BULOH Selangor, Malaysia, 40160
- Owner or operator
- SUPERVISION OPTIMAX SDN BHD (10053723)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 4, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2018 | K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Supervision Optimax Sdn Bhd | accessdata.fda.gov |
| January 4, 2017 | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | LPL | Substantially Equivalent | Supervision Optimax Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated June 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.