Pure Global
241122
III
current

Lasers, Femtosecond Pulseๆฟ€ๅ…‰,้ฃž็ง’่„‰ๅ†ฒ

This profile provides complete Hong Kong MDACS registration information for Lasers, Femtosecond Pulse. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Lasers, Femtosecond Pulse

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
28161
Product Code Detail
28161 Lasers, Femtosecond Pulse
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
AMO Manufacturing USA, LLC.
Amo Manufacturing Usa, Llc
United States
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510 Cottonwood Drive, Milpitas, California 95035 United States
510 Cottonwood Drive, Milpitas, California 95035 ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
ELITA Femtosecond Laser System (0155-1001), ELITA Patient Interface (20-pack) (0155-1825), ELITA Patient Interface (1-pack) (0155-2030)
ELITA ้ฃž็ง’ๆฟ€ๅ…‰็ณป็ปŸ (0155-1001), ELITA ๆ‚ฃ่€…ๆŽฅๅฃ (20 ไปถ่ฃ…) (0155-1825), ELITA ๆ‚ฃ่€…ๆŽฅๅฃ (1 ไปถ่ฃ…) (0155-2030)