PMA · Approved
ApprovedQuantel Activis Laser and ZSL30 Act, ZSL120 Act, and Hsbmbq Act Slit Lamp Adapters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch + Lomb Ireland Limited · MVF System, Laser, Photodynamic Therapy
Approved on Apr 4, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 264-day review.
- Decided
- Apr 4, 2006
- Review
- 264 days
- Class
- Class III
- Product code
- MVF
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050026 has 3 supplements since 2013: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2013 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MVF devicesMVF System, Laser, Photodynamic Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVF
Too few MVF 510(k)s in any year since 2007 to give a median.
Recalls per year · MVF
No recall names MVF since 2007.
Adverse event reports per year · MVF
5in 2025
MAUDE reports naming product code MVF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P050026 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050026: Quantel Activis Laser and ZSL30 Act, ZSL120 Act, and Hsbmbq Act Slit Lamp Adapters.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050026
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026