Identity
- Trade Name
- IPL Treatment Systems EUDAMEDApolomed FDA UDI
- Generic Name
- Intense pulsed light skin surface treatment system FDA UDI
- Device Name
- Intense Pulsed Light Skin Surface Treatment Systems EUDAMEDIPL (Intense Pulsed Light) Treatment Systems FDA UDI
- Model / Reference
- HS-650 EUDAMEDFDA UDI6505 EUDAMED
- Description
- IPL (Intense Pulsed Light) Treatment Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745916505 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745916505 EUDAMED
- 510(k) Number
- K093627 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
- Czechia EUDAMED
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Red-light phototherapy unit, professional
IPL Treatment Systems by Shanghai Apolo Medical Technology Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Red-light phototherapy unit, professional.
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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-06970745916505 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Apolo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002904
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f37dc092-6a14-4bec-b454-280a0e1a9cb4 61 fields · synced Aug 2, 2026
- FDA UDI e5eab6fb-161a-4c17-8931-041dbae74f26 36 fields · synced May 29, 2026