FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
FDA 510(k) clearance K982997 · decided 1999-01-20
Clearance details
- K-number
- K982997
- Device name
- FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
- Applicant
- Aspect Vision Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-27
- Decision date
- 1999-01-20
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Freehold, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.