FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K Number: K182249
·
Decision Nov 30, 2018
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
23
Review Days
102
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Basic Information
- Device Name
- Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
- K Number
- K182249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb, Incorporated
- Date Received
- August 20, 2018
- Decision Date
- November 30, 2018
- 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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