Identity
- Trade Name
- HELIOS 785 Pico Arm FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- HELIOS 785 Pico (1754V2) Arm FDA UDI
- Model / Reference
- HELIOS 785 Pico (1754V2) Arm FDA UDI
- Description
- HELIOS 785 Pico (1754V2) Arm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800035501877 FDA UDI
- 510(k) Number
- K243780 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical 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: General/multiple surgical frequency-doubled solid-state laser system
HELIOS 785 Pico Arm by Laseroptek Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical frequency-doubled solid-state laser system.
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Cleared under the same submission
K243780 also covers:
- HELIOS 785 Pico 1064 FX Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico 532 FX Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico 785 Collimator Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico 785 Zoom Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico Body — Laseroptek Co., Ltd
- HELIOS 785 Pico DIA FX 785 Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico DIA FX 785 s Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico Foot Switch — Laseroptek Co., Ltd
- HELIOS 785 Pico User Manual — Laseroptek Co., Ltd
- HELIOS 785 Pico Zoom Collimator Handpiece — Laseroptek Co., Ltd
- HELIOS 785 Pico 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laseroptek Co., Ltd
Sources (1)
- FDA UDI 8fdf44b1-0c1b-4800-9df9-fd5de03d7f41 35 fields · synced May 30, 2026