FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K Number: K002589
·
Decision Oct 23, 2000
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
119
Applicant Total
5
Review Days
63
Basic Information
- Device Name
- OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
- K Number
- K002589
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ALCON UNIVERSAL, LTD.
- Date Received
- August 21, 2000
- Decision Date
- October 23, 2000
- Product Code
- LPN
- 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
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Other Clearances by ALCON UNIVERSAL, LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K021143 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Aug 8, 2002 | Substantially Equivalent |
| K001214 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Jul 10, 2000 | Substantially Equivalent |
| K001235 | OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 | Jul 3, 2000 | Substantially Equivalent |
| K000385 | OPTI-FREE EXPRESS LENS DROPS | Apr 28, 2000 | Substantially Equivalent |