FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICASE
K Number: K021248
·
Decision Sep 24, 2002
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
81
Applicant Total
1
Review Days
158
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Basic Information
- Device Name
- ICASE
- K Number
- K021248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ikeeps, Inc.
- Date Received
- April 19, 2002
- Decision Date
- September 24, 2002
- Product Code
- LRX
- 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 |
|---|---|---|---|
| LRX | Case, Contact Lens | FDA class 2 | Ophthalmic |
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