Identity
- Trade Name
- PicoLO User Manual FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- PicoLO User Manual (Rev.3) FDA UDI
- Model / Reference
- Rev.3 FDA UDI
- Description
- PicoLO User Manual (Rev.3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800035501150 FDA UDI
- 510(k) Number
- K183392 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological frequency-doubled solid-state laser system 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 frequency-doubled solid-state laser system
PicoLO User Manual by Laseroptek Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183392 also covers:
- PicoLO 1064 Handpiece — Laseroptek Co., Ltd
- PicoLO 1064 Handpiece — Laseroptek Co., Ltd
- PicoLO 532 Handpiece — Laseroptek Co., Ltd
- PicoLO Arm — Laseroptek Co., Ltd
- PicoLO Body — Laseroptek Co., Ltd
- PicoLO Collimator Handpiece — Laseroptek Co., Ltd
- PicoLO Foot Switch — Laseroptek Co., Ltd
- PicoLO Power cable — Laseroptek Co., Ltd
- PicoLO Service Manual — Laseroptek Co., Ltd
- PicoLO User Manual — Laseroptek Co., Ltd
- PicoLO User Manual — Laseroptek Co., Ltd
- PicoLO Zoom Handpiece — Laseroptek Co., Ltd
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 |
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Manufacturer
- Manufacturer
- Laseroptek Co., Ltd
Sources (1)
- FDA UDI aa7bb5d8-b665-48ba-aa2d-eda424c72bd0 35 fields · synced May 30, 2026