FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
K Number: K000998
·
Decision Jun 5, 2000
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
1
Review Days
74
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Basic Information
- Device Name
- OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
- K Number
- K000998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optisonic, Inc.
- Date Received
- March 23, 2000
- Decision Date
- June 5, 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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