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Femto Ldv Z2
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 510.003.002Model FEMTO
Identity
- Trade Name
- FEMTO LDV Z2 EUDAMEDFEMTO LDV FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Device Name
- FEMTO LDV Z2 EUDAMED
- Model / Reference
- FEMTO EUDAMED510.003.002 EUDAMEDZ2 FDA UDI
Identifiers
- Catalog Number
- 510.003.002 FDA UDI
- Primary DI / UDI-DI
- 07640167750047 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775FLMDEVGN EUDAMED
- 510(k) Number
- K112154 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Q020199 OPHTHALMIC CUTTING DEVICES - OTHER EUDAMED
- GMDN Term
- Femtosecond ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Femto Ldv Z2 by SIE AG, Surgical Instrument Engineering — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112154 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 764016775FLMDEVGN | Class IIb | Active |
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Manufacturer
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- EUDAMED SRN
- CH-MF-000025018
- Authorised Representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Sources (3)
- EUDAMED af8a7483-b4fc-4a34-abac-927948b0f3bc 61 fields · synced Jul 17, 2026
- FDA UDI 2fce4bff-540d-4ef7-8e3c-24f2371ae352 36 fields · synced May 29, 2026
- FDA 510(k) K112154 1 fields · synced May 18, 2026