510(k) · Cleared
ClearedLevia Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lerner Medical Devices, Inc. · FTC Light, Ultraviolet, Dermatological
Cleared on Feb 13, 2004 as substantially equivalent to K022165 (Theralight, Inc., 2002) and 5 other predicates after a 31-day review. Its family tree reaches back 5 generations to 1989. 280 later devices descend from it.
- Decided
- Feb 13, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K885026 (1989). 16 ancestors in all, the oldest K885025 (1989). 280 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 4 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 3 generations backK020591 BclearLumenis · 2002
- 2 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 1 generation backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- This deviceK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- Descendant · cites it directly · 274 of its ownK051428 Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 4 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
Showing 5 of 280 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 280 · See all- K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005 · cites it directly274descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 4 generations on92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −4 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −3 | K020591 | Bclear | Lumenis | 2002 | — |
| −2 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −1 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| 0 (this device) | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| +1 | K051428 | Vtrac Excimer Lamp System | Photo Medex, Inc. | 2005 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +4 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 0 |
| 2017 | 19 | 0 |
| 2018 | 17 | 0 |
| 2019 | 12 | 0 |
| 2020 | 23 | 0 |
| 2021 | 17 | 0 |
| 2022 | 26 | 0 |
| 2023 | 19 | 0 |
| 2024 | 32 | 0 |
| 2025 | 31 | 0 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) 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 FTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTC device
- #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Summary page 1…of Predicate Devices: TheraLight, Inc. UV 1 20-2 UVA / UVB Phototherapy System K022165, K024020, Lumenis, Ltd. BCIear UVB Phototherapy Sy… | 2002 |
| * | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy SystemSummary page 1…cate Devices: TheraLight, Inc. UV 1 20-2 UVA / UVB Phototherapy System K022165, K024020, Lumenis, Ltd. BCIear UVB Phototherapy System… | 2003 |
| * | K020591 | BclearSummary page 1…24020, Lumenis, Ltd. BCIear UVB Phototherapy System K020591, K021762 National Biological, Corp. Handisol Wound… | 2002 |
| * | K021762 | BclearSummary page 1…Lumenis, Ltd. BCIear UVB Phototherapy System K020591, K021762 National Biological, Corp. Handisol Wound Healing… | 2002 |
| * | K982082 | Handisol Wound HealingSummary page 1…2 National Biological, Corp. Handisol Wound Healing K982082 National Biological, Corp. Panosol II UVB-206… | 1998 |
| * | K904427 | Panosol II Uvb-206Summary page 1…82082 National Biological, Corp. Panosol II UVB-206 K904427 510(k) Application: Lerner Medical Devices, Inc., Levia Phototherapy System Page 9… | 1990 |
What descends from it? (280)
See all 2803 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K051428 (Photo Medex, Inc., 2005) has gone furthest, with 274 descendants of its own.
- 6 other devices also cite its predicate K022165.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, 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 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
What is it indicated for?
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040062: Levia Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040062
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026