Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
FDA 510(k) clearance K222954 · decided 2023-03-13
Clearance details
- K-number
- K222954
- Device name
- Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
- Applicant
- Innova Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-27
- Decision date
- 2023-03-13
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Hsinchu, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.