Medical Device Division · registration 220135ActiveGyrus
Hong KongLaser Delivery Systems, FiberopticClass IIIGyrus ACMI, Inc.
Official record identity
- MDACS listing number
- 220135
- Model name
- Soltive Premium SuperPulsed Laser System (TFL-PLS), Footswitch, Wired footswitch (TFL-AFSW), Footswitch, Wireless footswitch (TFL-AFSWL)
- Registration date
- April 29, 2022
- Expiry date
- April 29, 2027
- Source update date
- November 26, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Olympus Hong Kong and China Limited
- Manufacturer
- Gyrus ACMI, Inc.
Official description
Laser Delivery Systems, Fiberoptic
Additional source fields
- AMD nomenclature code
- 17807
- Local responsible person phone
- 21705678
- Published manufacturer address
- 9600 Louisiana Ave. North, Brooklyn Park, MN 55445, USA
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.