← Back to catalogue
Medical Intense Pulsed Light Treatment System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref HM-IPL-B3
Identity
- Trade Name
- Huamei FDA UDI
- Generic Name
- Intense pulsed light skin surface treatment system FDA UDI
- Device Name
- Medical Intense Pulsed Light Treatment System EUDAMED
- Model / Reference
- HM-IPL-B3 EUDAMEDIPL-B3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973512860025 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973512860025 EUDAMED
- 510(k) Number
- K192521 FDA UDI
- FDA Product Code
- ONF FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Intense pulsed light skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Red-light phototherapy unit, professional
Medical Intense Pulsed Light Treatment System by Shandong Huamei Technology Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Red-light phototherapy unit, professional.
- Lumie Brazil — Outside In (Cambridge) Ltd trading as Lumie · Class IIa
- Controller Unit (CU+) — MEDI-TECH INTERNATIONAL CORPORATION · Class II
- PRO WELLNESS — PHOTON 4 HEALTH B.V. · Class I
- Shark cryoglow — SharkNinja Operating LLC · Class IIa
- Bodyclock Luxe 700FM — Outside In (Cambridge) Ltd trading as Lumie · Class I
- BASIC MIND WELLNESS SYSTEM® — PHOTON 4 HEALTH B.V. · Class I
- Ströme Energy+ — Zero-Plus International Limited · Class IIa
- HYDRO 4 HEALTH® LASER ATP WRISTBAND — PHOTON 4 HEALTH B.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973512860025 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025482
- Authorised Representative
- Tech4beauty GmbH DE-AR-000024345
Sources (2)
- EUDAMED 87ce1cb6-2244-42dd-897d-633092b0b0bb 61 fields · synced Jul 26, 2026
- FDA UDI a73e9c4d-c102-406c-8418-d3ba60e83848 33 fields · synced May 30, 2026