Identity
- Trade Name
- HELIOS Ⅱ Arm FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- HELIOS Ⅱ Arm FDA UDI
- Model / Reference
- HELIOS Ⅱ Arm FDA UDI
- Description
- HELIOS Ⅱ Arm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800035500139 FDA UDI
- 510(k) Number
- K083203 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 Ⅱ 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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- Powered Laser Surgical Instrument－Nice Station Light Based Platform — Beijing Syntech Laser Co., Ltd. · Class II
- Scan attachable delivery unit (SL130) — Nidek, Inc. · Class II
- GreenLight™ Laser System Footswitch — Boston Scientific · Class II
- BIO delivery unit (Keeler) — Nidek, Inc. · Class II
Cleared under the same submission
K083203 also covers:
- HELIOS Ⅱ 1064 Fractional Handpiece — Laseroptek Co., Ltd
- HELIOS Ⅱ 532 Fractional Handpiece — Laseroptek Co., Ltd
- HELIOS Ⅱ Collimator Handpiece — Laseroptek Co., Ltd
- HELIOS Ⅱ Foot Switch — Laseroptek Co., Ltd
- HELIOS Ⅱ Service Manual — Laseroptek Co., Ltd
- HELIOS Ⅱ User Manual — Laseroptek Co., Ltd
- HELIOS Ⅱ Zoom Handpiece — Laseroptek Co., Ltd
- HELIOS Ⅱ body — Laseroptek Co., Ltd
- HELIOS Ⅱ power cable — 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 387980c3-52db-4a27-bff4-317c117012e0 35 fields · synced Jun 8, 2026