FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
K Number: K030167
·
Decision Apr 2, 2003
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
4
Review Days
76
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Basic Information
- Device Name
- MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
- K Number
- K030167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clearlab Pte , Ltd.
- Date Received
- January 16, 2003
- Decision Date
- April 2, 2003
- 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 Clearlab Pte , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K052290 | AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS | May 15, 2006 | Substantially Equivalent |
| K030748 | AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER | May 14, 2003 | Substantially Equivalent |
| K003833 | SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Feb 13, 2001 | Substantially Equivalent |