Singapore HSA registration DE0003113
JJSV Laminar® Flow Phaco Tips, Flared
Singapore·CLASS B·Johnson & Johnson Surgical Vision, Inc.·Registered February 07, 2006Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0003113
- Registration Date
- February 07, 2006
- Change Notification Approval Date
- October 20, 2023
- Retention Due Date
- December 31, 2025
Product description
The tips are utilized in conjunction with the SOVEREIGN®, SERIES III™, SERIES 4™ and PROFINESSE II® Phaco Handpieces during the phacoemulsification procedure to break up the nucleus of the cataractous lens and remove the remaining nuclear fragments. The handpieces have been designed for use with the AMO families of phacoemulsification machines. The LAMINAR® Flow Phaco Tips are supplied sterile and are designed as reusable products for use up to 20 times.
Product Owner
- Short Name
- Johnson & Johnson Surgical Vision, Inc.
- Address
- 31 Technology Drive, Suite 200, Irvine, CA 92618, UNITED STATES
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model information
- Model Name(s)
- Tip 0° Tip 30°
- Model Identifier(s)
- OPOF0019L OPOF3019L
About this record
Access comprehensive regulatory information for JJSV Laminar® Flow Phaco Tips, Flared in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0003113 and owned by Johnson & Johnson Surgical Vision, Inc.. The device was registered on February 07, 2006.
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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