FEMTO LDV Z8 Femtosecond Surgical Laser
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- FEMTO LDV Z8 EUDAMEDFEMTOLDV FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Device Name
- FEMTO LDV Z2 EUDAMED
- Model / Reference
- FEMTO EUDAMED510.003.008 EUDAMEDZ8 FDA UDI
Identifiers
- Catalog Number
- 510.003.008 FDA UDI
- Primary DI / UDI-DI
- 07640167750016 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775FLMDEVGN EUDAMED
- FDA Product Code
- OOE FDA 510(k)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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)FDA UDI
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The FEMTO LDV Z8 Femtosecond Surgical Laser is an ophthalmic femtosecond laser, designed for precise tissue ablation and incision in corneal and cataract surgeries. It employs ultra-short laser pulses to perform minimally invasive procedures, including corneal flap creation, lens fragmentation, and capsulotomy, enhancing surgical accuracy and reducing trauma to surrounding tissues.
This device is supplied as a reusable, non-sterile system intended for use in a sterile surgical environment, typically within an operating room. It features an articulated arm for flexible positioning and integration with existing surgical setups, requiring no patient relocation during procedures. Authorized under FDA 510(k) and MDR compliance, the FEMTO LDV Z8 operates under the regulatory classification of Class II (Ophthalmic Laser, Product Code OOE) and adheres to 21 CFR 886.4390.
Frequently asked questions
What types of ophthalmic surgeries is the FEMTO LDV Z8 Femtosecond Surgical Laser primarily used for?
The FEMTO LDV Z8 is designed for minimally invasive corneal and cataract surgeries, specifically for precise tissue ablation. It is used to create corneal flaps, fragment lenses, and perform capsulotomies, which helps improve surgical accuracy and reduce trauma to surrounding tissues.
Is the FEMTO LDV Z8 Femtosecond Surgical Laser a single-use or reusable device, and how is it prepared for use?
The FEMTO LDV Z8 is a reusable system that is intentionally supplied in a non-sterile state. It must be sterilized and prepared in a sterile surgical environment, such as an operating room, before use. The articulated arm design allows for flexible integration with existing surgical setups without requiring patient relocation.
What regulatory pathways has the FEMTO LDV Z8 Femtosecond Surgical Laser followed, and what classification does it hold?
The FEMTO LDV Z8 has been authorized under both the FDA 510(k) pathway and the EU Medical Device Regulation (MDR). It is classified as a Class II device under the FDA’s Product Code OOE (Ophthalmic Laser) and adheres to 21 CFR 886.4390, ensuring compliance with stringent regulatory standards for ophthalmic lasers.
How does the FEMTO LDV Z8 Femtosecond Surgical Laser integrate with existing surgical setups in the operating room?
The device features an articulated arm, which allows for flexible positioning and seamless integration with current surgical environments. This design eliminates the need for patient relocation during procedures, enhancing workflow efficiency and adaptability in the operating room.
What is the primary advantage of using ultra-short laser pulses in procedures performed with the FEMTO LDV Z8?
Ultra-short laser pulses enable the FEMTO LDV Z8 to perform highly precise tissue ablation with minimal thermal damage to surrounding structures. This precision reduces trauma, improves surgical outcomes, and supports techniques like corneal flap creation and lens fragmentation in cataract surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FEMTO LDV Z8 Femtosecond Surgical Laser (K213559) — FDA 510 (k ..., PDF FEMTO_LDV_Z-Models_Applications_Brochure_210x279mm, PDF FEMTO_LDV_Z8_Brochure_210x279mm - Oertli Ophthalmedic
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213559 | Class II | Active |
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Manufacturer
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- FDA Applicant
- Sie Ag,Surgical Instrument Engineering
Sources (3)
- FDA 510(k) K213559 24 fields · synced Sep 18, 2026
- FDA UDI 84d589c0-a7d3-44f1-ae95-bea750dc9481 36 fields · synced May 29, 2026
- EUDAMED 04063fff-0b3b-4e73-a15b-a2dd19ffebab 61 fields · synced Jul 9, 2026