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Singapore HSA registration DE0503279

AMO CATALYS Precision Laser System

Singapore flagSingapore·CLASS C·AMO Manufacturing USA LLC·Registered June 25, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0503279
Registration Date
June 25, 2019
Change Notification Approval Date
July 02, 2024
Retention Due Date
June 24, 2025
Product description
The CATALYS Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Product Owner
Name
AMO Manufacturing USA LLC
Short Name
AMO
Address
510 Cottonwood Drive, Milpitas, CA 95035, UNITED STATES
Registrant
Name
AMO SINGAPORE PTE. LIMITED
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
AMO SINGAPORE PTE. LIMITED
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
Mobile Patient Bed Catalys Precision Laser System LIQUID OPTICS Interface-12 LIQUID OPTICS Interface Catalys Precision Laser System
Model Identifier(s)
0160-6000 0160-6010 0180-1201 0180-1401 Catalys-I
About this record

Access comprehensive regulatory information for AMO CATALYS Precision Laser System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503279 and owned by AMO Manufacturing USA LLC. The device was registered on June 25, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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