Taiwan FDA registration b8e1ad560bef4020628627d35406a832
“LASEROPTEK” Helios 785 pico Fractional Q-switched Nd:YAG Laser System
TW: “雷射歐普克”海力神皮秒釹雅鉻雷射系統
Registration details
- Analysis ID
- b8e1ad560bef4020628627d35406a832
- License Form
- Ministry of Health Medical Device Import No. 036685
- Customs Code
- DHA05603668507
Company information
- Manufacturer
- LASEROPTEK Co., Ltd.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- WOH MEDICAL CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- I4810 Lasers for general surgery, plastic surgery and dermatology
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 01, 2023
- Expiry Date
- Aug 01, 2028
About this record
Access comprehensive regulatory information for “LASEROPTEK” Helios 785 pico Fractional Q-switched Nd:YAG Laser System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b8e1ad560bef4020628627d35406a832 and manufactured by LASEROPTEK Co., Ltd.. The authorized representative in Taiwan is WOH MEDICAL CO., LTD..
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