ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
FDA 510(k) clearance K141280 · decided 2014-07-18
Clearance details
- K-number
- K141280
- Device name
- ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
- Applicant
- Seinoh Optical Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-16
- Decision date
- 2014-07-18
- Days to decision
- 63 days
- Clearance type
- Abbreviated
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.