Identity
- Trade Name
- HYPERION User Manual FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- HYPERION User Manual FDA UDI
- Model / Reference
- HYPERION User Manual FDA UDI
- Description
- HYPERION User Manual FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800035500467 FDA UDI
- 510(k) Number
- K132286 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological 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 solid-state laser system
HYPERION User Manual by Laseroptek Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological solid-state laser system.
- CLARITY II — Lutronic Corporation · Class II
- AuraLux — Acclaro Corporation · Class II
- GentleMax Pro — Candela Corporation · Class II
- CLARITY II — Lutronic Corporation · Class II
- GentleYAG — Candela Corporation · Class II
- Splendor X — Bios, Inc. · Class II
- EPY-50 — DDC TECHNOLOGIES, INC. · Class II
- Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II
Cleared under the same submission
K132286 also covers:
- HYPERION Arm — Laseroptek Co., Ltd
- HYPERION Blue Handpiece — Laseroptek Co., Ltd
- HYPERION FIBER — Laseroptek Co., Ltd
- HYPERION Foot Switch — Laseroptek Co., Ltd
- HYPERION Gold Handpiece — Laseroptek Co., Ltd
- HYPERION Red Handpiece — Laseroptek Co., Ltd
- HYPERION Service Manual — Laseroptek Co., Ltd
- HYPERION body — Laseroptek Co., Ltd
- HYPERION 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 |
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Manufacturer
- Manufacturer
- Laseroptek Co., Ltd
Sources (1)
- FDA UDI 11a6ce61-cef9-4c02-88f9-f6fde0c00465 35 fields · synced Jun 6, 2026