Identity
- Trade Name
- Laserconn EUDAMEDFDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- DIODE LASER HAIR REMOVAL SYSTEM FOR MEDICAL USE EUDAMEDDiode Laser Hair Removal Systems for Medical Use-Milestone Smart-M is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. FDA UDI
- Model / Reference
- MILESTONE SMART-M EUDAMEDFDA UDI
- Description
- Diode Laser Hair Removal Systems for Medical Use-Milestone Smart-M is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. FDA UDI
Identifiers
- Catalog Number
- Diode Laser Hair Removal System FDA UDI
- Primary DI / UDI-DI
- 06972558160038 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972558160038 EUDAMED
- 510(k) Number
- K222800 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological laser beam guiding handpiece 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 235 Millimeter FDA UDIWidth — 435 Millimeter FDA UDILength — 355 Millimeter FDA UDI
Laserconn by Sanhe Laserconn Tech Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-06972558160038 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Sanhe Laserconn Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000028667
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED ed320d00-f8b8-4424-bfab-4c760a529300 61 fields · synced Jul 19, 2026
- FDA UDI 637b0fad-c9f9-4c92-b201-f64b89d53fe4 38 fields · synced May 30, 2026