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Singapore HSA registration DE0007018

AMO STAR® S4 IR Excimer Laser System

Singapore flagSingapore·CLASS C·AMO Manufacturing USA LLC·Registered June 16, 2011
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
HSA Product Code
Refer to CRPNS
HS Code
90132000
Registration information
Registration Number
DE0007018
Registration Date
June 16, 2011
Change Notification Approval Date
July 12, 2018
Retention Due Date
June 15, 2025
Product description
AMO STAR® S4 IR Excimer Laser System is an ultraviolet laser which is used in eye surgery for Photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) which corrects refractive errors of the eyes.
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)
KIT,STAR S4 IRIS REGISTRATION EXCIMER LASER SYSTEM, STAR S4 IR CE VSS Refractive Offline Programming Module
Model Identifier(s)
0030-4429 0030-4966 0120-0190
About this record

Access comprehensive regulatory information for AMO STAR® S4 IR Excimer 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 DE0007018 and owned by AMO Manufacturing USA LLC. The device was registered on June 16, 2011.

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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