SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
FDA 510(k) clearance K111345 · decided 2011-11-02
Clearance details
- K-number
- K111345
- Device name
- SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
- Applicant
- The See Clear Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-13
- Decision date
- 2011-11-02
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.