Identity
- Trade Name
- FEMTO LDV FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Model / Reference
- med-profile FDA UDI
Identifiers
- Catalog Number
- 510.002.003 FDA UDI
- Primary DI / UDI-DI
- 07640167750054 FDA UDI
- 510(k) Number
- K053511 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Femtosecond ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Femtosecond ophthalmic solid-state laser system
Femto Ldv by Sie Ltd Surgical Instrument Engineering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Femtosecond ophthalmic solid-state laser system.
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- LENSAR LLS-fs 3D — LENSAR · Class II
- ELITA — Johnson & Johnson Surgical Vision, Inc. · Class II
- CATALYS SYSTEM — OptiMedica Corp. · Class II
- CATALYS SYSTEM — Johnson & Johnson Surgical Vision, Inc. · Class II
Cleared under the same submission
K053511 also covers:
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sie Ltd Surgical Instrument Engineering
Sources (1)
- FDA UDI aec80e0f-0fca-4629-9dd0-8b66335c809e 36 fields · synced Jun 1, 2026