Identity
- Trade Name
- Digital DuetTM EUDAMEDDigital Duet™ FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Model / Reference
- NA EUDAMEDGAS900000DIGBe EUDAMEDDigital Duet™ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810096330017 EUDAMEDFDA UDI
- Basic UDI-DI
- 081009633SLTDX EUDAMED
- 510(k) Number
- K220877 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- 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
- Italy 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
GAS900000DIGBe by Lumenis Be, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081009633SLTDX | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lumenis Be Inc
- EUDAMED SRN
- US-MF-000016037
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (3)
- EUDAMED 3093e072-f259-4ab4-979f-c8781c57d921 61 fields · synced Jun 19, 2026
- FDA UDI f2555d38-f3ea-499b-98b6-fb1df7d08ad1 33 fields · synced May 30, 2026
- EUDAMED c46b9970-45fa-4c12-8468-0300524fa03d 61 fields · synced Jun 19, 2026