FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
FEMTO LDV Z8 Femtosecond Surgical Laser
K Number: K213559
·
Decision Apr 21, 2022
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
2
Review Days
168
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Basic Information
- Device Name
- FEMTO LDV Z8 Femtosecond Surgical Laser
- K Number
- K213559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sie Ag,Surgical Instrument Engineering
- Date Received
- November 4, 2021
- Decision Date
- April 21, 2022
- Product Code
- OOE
- 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 |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | FDA class 2 | Ophthalmic |
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Other Clearances by Sie Ag,Surgical Instrument Engineering
| K Number | Device Name | ||
|---|---|---|---|
| K150323 | FEMTO LDV Z8 Surgical Laser | Oct 23, 2015 | Substantially Equivalent |