Identity
- Trade Name
- PICO-K EUDAMED
- Device Name
- Nd:YAG Surgical Laser Equipment EUDAMED
- Model / Reference
- PICO-K EUDAMEDPK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800209800003 EUDAMED
- Basic UDI-DI
- B-08800209800003 EUDAMED
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pico-K by Speclipse, Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253342 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08800209800003 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Speclipse, Inc.
- EUDAMED SRN
- KR-MF-000026775
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED cac65710-bf6b-435d-8119-b9afb511d81b 61 fields · synced Jul 8, 2026
- FDA 510(k) K253342 1 fields · synced May 18, 2026