FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K Number: K112192
·
Decision Oct 25, 2011
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
24
Applicant Total
92
Review Days
88
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Basic Information
- Device Name
- NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
- K Number
- K112192
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- July 29, 2011
- Decision Date
- October 25, 2011
- Product Code
- MVN
- 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 |
|---|---|---|---|
| MVN | Lens, Contact, (Disposable) | FDA class 2 | Ophthalmic |
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