Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens
FDA 510(k) clearance K181349 · decided 2018-09-19
Clearance details
- K-number
- K181349
- Device name
- Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens
- Applicant
- Visco Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-21
- Decision date
- 2018-09-19
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Taoyuan City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.