Identity
- Trade Name
- HELIOS III User Manual FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- HELIOS III User Manual(Rev.3) FDA UDI
- Model / Reference
- Rev.3 FDA UDI
- Description
- HELIOS III User Manual(Rev.3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800035501129 FDA UDI
- 510(k) Number
- K152856 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 III User Manual 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
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Cleared under the same submission
K152856 also covers:
- HELIOS III 1064 Handpiece — Laseroptek Co., Ltd
- HELIOS III 532 Handpiece — Laseroptek Co., Ltd
- HELIOS III Arm — Laseroptek Co., Ltd
- HELIOS III Collimator Handpiece — Laseroptek Co., Ltd
- HELIOS III Foot Switch — Laseroptek Co., Ltd
- HELIOS III Power Cable — Laseroptek Co., Ltd
- HELIOS III Service Manual — Laseroptek Co., Ltd
- HELIOS III User Manual — Laseroptek Co., Ltd
- HELIOS III Zoom Handpiece — Laseroptek Co., Ltd
- HELIOS III body — Laseroptek Co., Ltd
- HELIOS Ⅲ 1064 Fractional Handpiece — Laseroptek Co., Ltd
- HELIOS Ⅲ 532 Fractional 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 87a8c9c0-d3d2-49f9-a0c1-7cd155084c4e 35 fields · synced May 30, 2026