← Back to catalogue
ALLY Adaptive Cataract Treatment System
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 70-00050-001
by Lensar
Identity
- Trade Name
- ALLY Adaptive Cataract Treatment System EUDAMEDALLY FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Device Name
- ALLY Adaptive Cataract Treatment System EUDAMED
- Model / Reference
- 70-00050-001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00867744000150 EUDAMEDFDA UDI
- Basic UDI-DI
- 08677440001ALLYUN EUDAMED
- 510(k) Number
- K220259 FDA UDI
- FDA Product Code
- OOE FDA UDI
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER 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
- Germany 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
Yes
FDA UDI
ALLY Adaptive Cataract Treatment System by Lensar — 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 | K220259 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 08677440001ALLYUN | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lensar
- EUDAMED SRN
- US-MF-000008522
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED ff00e01c-c972-4b41-bb57-7458382772b8 61 fields · synced Aug 1, 2026
- FDA UDI 19f0a229-bd9c-4e1b-880b-a9a24b97482d 36 fields · synced May 30, 2026
- FDA 510(k) K220259 1 fields · synced May 18, 2026