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Singapore HSA registration DE0502784

Bausch & Lomb Stellaris Elite Vision Enhancement System

Singapore flagSingapore·CLASS C·Bausch & Lomb Inc.·Registered February 20, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0502784
Registration Date
February 20, 2019
Change Notification Approval Date
August 14, 2024
Retention Due Date
February 19, 2026
Product description
The Bausch + Lomb Stellaris Elite 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 Bausch + Lomb Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
Product Owner
Name
Bausch & Lomb Inc.
Short Name
Bausch & Lomb Inc.
Address
1400 North Goodman Street, Rochester, NY 14609, UNITED STATES
Registrant
Name
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Importer
Name
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Model information
Model Name(s)
Stellaris Elite (Anterior model) Stellaris Elite (Posterior/Combined model) Stellaris Elite (Posterior/Combined with Laser model) 23G Vitesse handpiece 255TD + ESA
Model Identifier(s)
BL11145 BL14455 BL15455 BL5631TD
About this record

Access comprehensive regulatory information for Bausch & Lomb Stellaris Elite Vision Enhancement 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 DE0502784 and owned by Bausch & Lomb Inc.. The device was registered on February 20, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C