Eu Mdd
Eu Md Class 2b
On The Market
๐บ๐ธ United States
Elite+
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 00841494100063
- Basic UDI-DI Code
- B-00841494100063
- Reference
- 100-7018-010
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Cynosure LLC
Additional Description
The Elite+ is a dual-wavelength, aesthetic laser that delivers laser energy in both the 1064-nm (Nd:Yag) and 755-nm (Alexandrite) wavelengths. Through various spot sizes, fluences and repetition rates, the system is primarily intended for hair removal, vascular lesions, benign pigmented lesions, and wrinkles. The products are non-sterile with instructions for proper cleanliness / sterilization for user.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12040218 | ENDERMOLOGY TREATMENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41319433-05 | INTERTEK SEMKO AB | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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