De Novo · Granted
GrantedLumenis Stellar M22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · QIU Intense Pulsed Light Device For Managing Dry Eye
Granted on Feb 23, 2021 as a new device type through De Novo after a 309-day review.
- Decided
- Feb 23, 2021
- Review
- 309 days
- Class
- Class II
- Product code
- QIU
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIU? 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?
De Novo 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 QIU devicesQIU Intense Pulsed Light Device For Managing Dry Eye: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIU
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QIU
Too few QIU 510(k)s in any year since 2007 to give a median.
Recalls per year · QIU
No recall names QIU since 2007.
Adverse event reports per year · QIU
1in 2023
MAUDE reports naming product code QIU, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for:
Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200028 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200028: Lumenis Stellar M22.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026