Identity
- Trade Name
- Refurbed PICO 532 Resolve HP, HiE FDA UDI
- Generic Name
- Dermatological laser beam producing handpiece FDA UDI
- Device Name
- Handpiece Assembly FDA UDI
- Model / Reference
- 7123-57-0209 FDA UDI
- Description
- Handpiece Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495022734 FDA UDI
- 510(k) Number
- K220853 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam producing handpiece 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
Yes
FDA UDI
Category: Dermatological laser beam producing handpiece
Refurbed PICO 532 Resolve HP, HiE by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological laser beam producing handpiece.
- LightSheer® Duet ET™ Handpiece — Lumenis Be, Inc. · Class II
- LightSheer® Duet HS™ Handpiece — Lumenis Be, Inc. · Class II
- PURE Laser, EPL810 HP — ENDYMED MEDICAL LTD · Class II
- Vbeam Aesthetica Delivery System — Candela Corporation · Class II
- Vbeam Aesthetica Distance Gauge Kit — Candela Corporation · Class II
- ASSY, DCD HAND PIECE, LARGE SPOT, GMPP — Candela Corporation · Class II
- FSE, PicoWay 785nm Handpiece — Candela Corporation · Class II
- GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly — Candela Corporation · Class II
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
- PicoWay Laser System — Candela Corporation
- Refurbed PICO 532 Resolve HP — Candela Corporation
- Refurbished Picoway 1064 Resolve Handpiece — Candela Corporation
- Refurbished Picoway Zoom Handpiece — Candela Corporation
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
- Candela Corporation
Sources (1)
- FDA UDI da8ce658-c065-476c-8d23-411c514ecd6f 34 fields · synced Jun 8, 2026