PicoWay Laser System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- PicoWay Laser System FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- Pulse Laser FDA UDI
- Model / Reference
- 9914-JB-9060 EUDAMEDFDA UDIPicoWay Laser System EUDAMED
- Description
- Pulse Laser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495023595 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817495023595 EUDAMED
- 510(k) Number
- K220853 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- L2499,Z12011006 EUDAMED
- GMDN Term
- Dermatological frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
Category: Dermatological frequency-doubled solid-state laser system
PicoWay Laser System by Candela Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K220853 also covers:
- FSE, PICO 730 Handpiece Assembly — Candela Corporation
- FSE, PicoWay 785nm Handpiece — Candela Corporation
- Kit, 785 HP and DG — Candela Corporation
- Refurbed PICO 532 Resolve HP — Candela Corporation
- Refurbed PICO 532 Resolve HP, HiE — Candela Corporation
- Refurbished Picoway 1064 Resolve Handpiece — Candela Corporation
- Refurbished Picoway Zoom Handpiece — Candela Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Candela Corporation
Sources (2)
- FDA UDI 0a3c6aaa-d898-401c-89b1-db8b2dd6a75a 35 fields · synced Jul 20, 2026
- EUDAMED 9150d72f-7dab-4746-b887-3600698725a5 61 fields · synced Jun 10, 2026