FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
K Number: K020927
·
Decision May 16, 2002
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
10
Review Days
56
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Basic Information
- Device Name
- BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
- K Number
- K020927
- 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
- Date Received
- March 21, 2002
- Decision Date
- May 16, 2002
- 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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| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Jan 9, 2014 | Substantially Equivalent |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Jan 3, 2014 | Substantially Equivalent |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Dec 27, 2013 | Substantially Equivalent |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | Sep 17, 2013 | Substantially Equivalent |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | May 16, 2013 | Substantially Equivalent |
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Jun 22, 2006 | Substantially Equivalent |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Jul 23, 2004 | Substantially Equivalent |