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IPL Treatment Systems
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 3009Model HS-300
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-300 EUDAMED3009 EUDAMEDHS-300C FDA UDI
- Description
- IPL(Intense Pulsed Light) Treatment Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745913009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745913009 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
- Spain 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 — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Also classified as Red-light phototherapy unit, professional.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200746 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970745913009 | Class IIb | Active |
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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 (3)
- EUDAMED 2902c347-ed6a-4153-94bf-66af3db015ad 61 fields · synced Jun 18, 2026
- FDA UDI 627f2cda-472f-4501-9ee7-8b218d9b5b87 36 fields · synced May 30, 2026
- FDA 510(k) K200746 1 fields · synced May 18, 2026