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Singapore HSA registration DE0013015

OPTIMEDICA CATALYS™ PRECISION LASER SYSTEM

Singapore flagSingapore·CLASS C·Optimedica Corporation·Registered May 27, 2013
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration information
Registration Number
DE0013015
Registration Date
May 27, 2013
Change Notification Approval Date
September 16, 2018
Retention Due Date
May 26, 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
Optimedica Corporation
Short Name
Optimedica Corporation
Address
1310 Moffett Park Drive, Sunnyvale, CA 94089, 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)
cOS 3.90 LIQUID OPTICS Interface-12 LIQUID OPTICS Interface Catalys Precision Laser System Key switch Joystick control Footswitch, Laser Footswitch, Vacuum Liquid Optics Interface Liquid Optics Interface Liquid Optics Interface Liquid Optics Interface Patient chair with headrest Touchscreen diplay (computer monitor) Daily Alignment Verification Pak cOS 3.00.06
Model Identifier(s)
0160-0144 0180-1201 0180-1401 Catalys-I EC-00169 EC-06171 EC-06194 EC-06195 LOI ( 20 units/carton) LOI ( Single Unit) LOI-12 LOI-12-BP SA-05130 SA-06554 SA-08044 SW-06395-3.00
About this record

Access comprehensive regulatory information for OPTIMEDICA 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 DE0013015 and owned by Optimedica Corporation. The device was registered on May 27, 2013.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C