Quantel Activis Laser and ZSL30 Act, ZSL120 Act, and Hsbmbq Act Slit Lamp Adapters
by Bausch + Lomb Ireland Limited
PMA P050026
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP050026 | Date4 Apr 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- System, laser, photodynamic therapy
- PMA Number
- FDA Product Code
- MVF
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The QuanteL Activis Laser and Slit Lamp Adapters are designed as an accessory system for photodynamic therapy. These adapters integrate with slit lamps to enable precise delivery of laser activation for Visudyne (verteporfin injection), facilitating targeted photodynamic treatment of choroidal neovascularization in conditions such as age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.
The adapters are supplied as reusable components for use with the Activis laser system, requiring compatibility with approved slit lamp models (ZSL30 ACT, ZSL120 ACT, HSBMBQ ACT). They are intended for clinical settings where photodynamic therapy is administered, with regulatory clearance under FDA PMA (P050026). Sterility and MRI safety are not specified, and their use is restricted to the indicated therapeutic applications as per the approved protocol.
Questions
AI-generated answers, 18 Sep 2026
Are these adapters compatible with all slit lamps, or only specific models? If so, which ones are approved for use?
These adapters are designed exclusively for use with approved slit lamp models: the ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT. They are not compatible with other slit lamp models, as their integration is critical for precise laser activation during photodynamic therapy with Visudyne.
How are the QuanteL Activis Laser and Slit Lamp Adapters supplied, and are they intended for single-use or reusable applications?
The adapters are supplied as reusable components, intended for repeated use within clinical settings where photodynamic therapy is administered. They are part of the Activis laser system and must be maintained according to manufacturer guidelines to ensure proper functionality and safety.
What specific conditions are these adapters approved to assist in treating, and how does their use relate to Visudyne?
These adapters are approved for photodynamic therapy using Visudyne (verteporfin injection) to treat choroidal neovascularization in patients with age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis. They enable precise laser activation to target the affected area during treatment.
Are these adapters sterile, and if not, what considerations should be taken for clinical use?
The device data does not specify sterility for these adapters. Since they are reusable, clinical settings must follow strict cleaning, disinfection, and maintenance protocols to prevent contamination and ensure safe, repeated use in photodynamic therapy procedures.
What regulatory pathway was followed for approval of these adapters, and what does that mean for their use in clinical practice?
The adapters were approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P050026. This means their safety and effectiveness were thoroughly evaluated by the FDA before clinical use, ensuring they meet stringent regulatory standards for photodynamic therapy applications as outlined in the approved protocol.