QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS

FDA Premarket Approval P050026

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the quantel activis laser and zsl30 act, zsl120 act, and hsbmbq act slit lamp adapters. The device is indicated for the photoactivation of the light activated drug visudyne (verteporfin for injection) in photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular hystoplasmosis.

• Device: QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
• Generic Name: System, Laser, Photodynamic Therapy
• Applicant: Bausch Health Ireland Limited
• Date Received: 2005-07-14
• Decision Date: 2006-04-04
• Notice Date: 2006-04-18
• PMA: P050026
• Supplement: S
• Product Code: MVF
• Docket Number: 06M-0162
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Bausch Health Ireland Limited 208 Val Des Bons Malades grand Duchy Of Luxembourg L-212-2121
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P050026		Original Filing
S002	2020-09-04	Normal 180 Day Track
S001	2012-11-19	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
06429810677020	P050026	002