Data / Medical devices / Malaysia / Visco Technology Sdn. Bhd
Visco Technology Sdn. Bhd: FDA-registered device maker in Prai Pulau Pinang, Malaysia, 10 510(k) clearances
Visco Technology Sdn. Bhd is registered with the FDA (registration 3009633067) in Prai Pulau Pinang, Malaysia. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 7, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009633067
- Address
- 2686 Jalan Todak Seberang Jaya, Prai Pulau Pinang, Malaysia, 13700
- Owner or operator
- Visco Vision Inc. (10052547)
- Roles
- Manufacturer
- First device listed
- August 14, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | 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 |
|---|---|---|---|---|---|---|
| December 7, 2020 | K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| July 15, 2020 | K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| October 2, 2019 | K191397 | OxySoft (olifilcon C) silicone hydrogel soft contact lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| September 13, 2019 | K183670 | Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| September 19, 2018 | K181349 | Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| April 20, 2018 | K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| December 5, 2017 | K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| October 24, 2016 | K160245 | Visco (olifilcon A) soft contact lens | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| May 26, 2016 | K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
| June 22, 2015 | K141348 | VISCO SOFT CONTACT LENS | LPL | Substantially Equivalent | Visco Vision, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 7, 2020. 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.