FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMTO LDV
K Number: K112154
·
Decision Mar 16, 2012
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
176
Applicant Total
1
Review Days
233
Basic Information
- Device Name
- FEMTO LDV
- K Number
- K112154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SIE AG,SURGICAL INSTUMENT ENGINEERING
- Date Received
- July 27, 2011
- Decision Date
- March 16, 2012
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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