Singapore HSA registration DE0003111
JJSV Laminar® Flow Phaco Tips and Infusion Sleeves
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
- DE0003111
- Registration Date
- February 07, 2006
- Change Notification Approval Date
- October 20, 2023
- Retention Due Date
- December 31, 2025
Product description
The LAMINAR® Flow Phaco Tips and Infusion Sleeves are utilized in conjunction with AMO phaco handpieces (excluding the PROFICIENT™ phaco handpiece during the phacoemulsification procedure. The tips are used to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments. The sleeves are used to deliver solution to the eye and cool the handpiece. The LAMINAR® Flow Phaco Tips and Infusion Sleeves are supplied sterile and are designed as reusable products for reuse 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 20 Gauge 0° Tip 20 Gauge 15° Tip 20 Gauge 30°
- Model Identifier(s)
- OPOR0020L OPOR1520L OPOR3020L
About this record
Access comprehensive regulatory information for JJSV Laminar® Flow Phaco Tips and Infusion Sleeves in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0003111 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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