Singapore HSA registration DE0006573
AMO iFS Advanced Femtosecond Laser System
Singapore·CLASS C·AMO Manufacturing USA LLC·Registered April 11, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Ophthalmology
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0006573
- Registration Date
- April 11, 2011
- Change Notification Approval Date
- December 01, 2023
- Retention Due Date
- April 10, 2026
Product description
The iFS Laser is a ophthalmic surgical laser with the following indications for use: • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments • In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal • In lamellar IEK and corneal harvesting • In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea • In the creation of a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK.
Product Owner
- Short Name
- AMO
- Address
- 510 Cottonwood Drive, Milpitas, CA 95035, UNITED STATES
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
- Model Name(s)
- Patient Interface (20 Procedure Pack Size) Patient Interface (2 Procedure Pack Size) iFS Advanced Femtosecond Laser System
- Model Identifier(s)
- 590106AN 660065AN J20007K
About this record
Access comprehensive regulatory information for AMO iFS Advanced Femtosecond 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 DE0006573 and owned by AMO Manufacturing USA LLC. The device was registered on April 11, 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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