FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
K Number: K183200
·
Decision Jan 9, 2019
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
1
Review Days
51
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Basic Information
- Device Name
- iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
- K Number
- K183200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C&E GP Specialist, Inc.
- Date Received
- November 19, 2018
- Decision Date
- January 9, 2019
- Product Code
- MUW
- 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 |
|---|---|---|---|
| MUW | Lens, Contact (Orthokeratology) | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUW), ordered by most recent decision date.
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AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
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