Pure Global AI
Medical Device Division · registration 190072Active

WaveLight

Hong KongLasers, Femtosecond PulseClass IIIWaveLight GmbH
Official record identity
MDACS listing number
190072
Model name
WaveLight FS200 with Disposable Set FS200 (8065990941) (Sapphire Blue (8065990714), Ivory White (8065998284), Ruby Red (8065998283), Midnight Black (8065998379), Royal Gold (8065998381)), Swiveling Patient Beds (Sapphire Blue (8065990896), Ruby Red (8065998289), Ivory White (8065998290), Midnight Black (8065998383), Royal Gold (8065998384)), WaveLight FS200 EasyPack Patient Interface (8065998298)
Registration date
January 09, 2024
Expiry date
March 01, 2029
Source update date
December 18, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class III
Official value: III
Published category
Lasers, Femtosecond Pulse
Published parties
Registrant / registration holder
Alcon Hong Kong, Limited
Manufacturer
WaveLight GmbH
Official description

Lasers, Femtosecond Pulse

Additional source fields
AMD nomenclature code
28161
Local responsible person phone
28959302(Surgical)/39727338(VisionCare)
Published manufacturer address
Am Wolfsmantel 5, 91058 Erlangen, Deutschland
Revision number
b
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.