FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
K Number: K982997
·
Decision Jan 20, 1999
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
5
Review Days
146
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Basic Information
- Device Name
- FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
- K Number
- K982997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspect Vision Care, Ltd.
- Date Received
- August 27, 1998
- Decision Date
- January 20, 1999
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Aspect Vision Care, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K980634 | FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Apr 22, 1998 | Substantially Equivalent |
| K973063 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR | Aug 26, 1997 | Substantially Equivalent |
| K971049 | FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | May 21, 1997 | Substantially Equivalent |
| K971164 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | May 21, 1997 | Substantially Equivalent |