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Bausch + Lomb Stellaris PC Vision Enhancement System with Laser - HSA Registration DE0019028

Access comprehensive regulatory information for Bausch + Lomb Stellaris PC Vision Enhancement System with Laser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019028 and owned by Bausch & Lomb Inc.. The device was registered on March 03, 2017.

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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CLASS C
DE0019028
Bausch + Lomb Stellaris PC Vision Enhancement System with Laser
HSA Registration Number: DE0019028
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Product Description

The Bausch + Lomb Stellaris PC Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculoplasty.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0019028
Registration Date
March 03, 2017
Retention Due Date
March 02, 2026
Product Owner
Short Name
Bausch & Lomb Inc.
Address
1400 North Goodman Street, Rochester, NY 14609, UNITED STATES
Registrant
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Importer
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Model Information
Model Name(s)
Stellaris PC V4 Software Upgrade Kit Stellaris V4 Software Upgrade Kit Anterior Deluxe System - VFM Anterior Deluxe System V4 - VFM Anterior Deluxe System - AFM Anterior Deluxe System V4 - AFM Stellaris Combined System with 532nm Laser and V4 Software Sterllaris PC Combined System Sterllaris Combined System V4 Remote Anterior System 532nm Laser Module 532nm Laser Upgrade Kit for Stellaris PC Anterior module with laser connection ports Integrated new design foot pedal Auxiliary footpedal for LIO use Multimedia Center Stellaris PC Foot Control Laser On/Off Keys (1 set) 532 Laser Safety Goggles Zeiss fixed ESF Leica Fixed ESF Adaptor for fitting of 2 position filters Interlock bypass connector kit Xenon Lamp Assy Mercury Vapor Lamp Assy Adapter, Alternate Mayo Tray Stellaris Zero Level Bottle Hanger Stellaris/Stellaris PC Zero Level Bottle Hanger (Double Ended) Alternate Mayo Tray – Plastic Bracket Foot Control Battery Foot Control Wall Charger Foot-Control Charger Adapter Stellaris Foot Control Charge Cradle Foot Control Power Cable 23 Ga Adjustable Chandelier 25 Ga Adjustable Chandelier 20GA Standard Laser Probe 20GA Soft Tip Aspirating Laser Probe 20GA Hard Tip Aspirating Laser Probe 20GA Curved Standard Laser Probe 20GA Illuminating Laser Probe 20GA Curved Illuminating Laser Probe 23GA Standard Laser Probe 23GA Soft Tip Aspirating Laser Probe 23GA Hard Tip Aspirating Laser Probe 23GA Curved Standard Laser Probe 23GA Illuminating Laser Probe 23GA Curved Illuminating Laser Probe 25GA Standard Laser Probe 25GA Curved Standard Laser Probe 25GA Illuminating Laser Probe 25GA Curved Illuminating Laser Probe
Model Identifier(s)
111025006 111025008 BL11110 BL11114 BL11120 BL11124 BL14304 BL1433 BL14334 BL2111 BL2271 BL2272 BL2273 BL2295 BL2296 BL2300 BL2390 BL3234 BL3235 BL3236 BL3237 BL3242 BL3244 BL3320 BL3321 BL4360 BL4362 BL4363 BL4364 BL4390 BL4391 BL4392 BL4393 BL4394 BL5234 BL5235 BL5290 BL5290ASP BL5290ASPH BL5290C BL5290L BL5290LC BL5293 BL5293ASP BL5293ASPH BL5293C BL5293L BL5293LC BL5295 BL5295C BL5295L BL5295LC