510(k) · Cleared
ClearedHandisol Wound Healing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Biological Corp. · FTC Light, Ultraviolet, Dermatological
Cleared on Oct 28, 1998 after a 135-day review. The FDA summary names its predicate without a number. 424 later devices descend from it.
- Decided
- Oct 28, 1998
- Review
- 135 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
424 later devices descend from it, 2 citing it directly.
- This deviceK982082 Handisol Wound HealingNational Biological Corp. · 1998
- Descendant · cites it directly · 280 of its ownK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- Descendant · 2 generations on · 274 of its ownK051428 Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005
- Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 4 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · cites it directly · 142 of its ownK043377 ZENOTyrell, Inc. · 2005
Showing 5 of 424 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 424 · See all- K040062Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004 · cites it directly280descendants
- K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005 · 2 generations on274descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 4 generations on198descendants
- K043377ZENOTyrell, Inc. · 2005 · cites it directly142descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| +1 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| +2 | K051428 | Vtrac Excimer Lamp System | Photo Medex, Inc. | 2005 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +4 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +1 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 13 | 0 |
| 2015 | 17 | 0 |
| 2016 | 21 | 0 |
| 2017 | 23 | 0 |
| 2018 | 23 | 0 |
| 2019 | 15 | 0 |
| 2020 | 24 | 0 |
| 2021 | 25 | 0 |
| 2022 | 36 | 0 |
| 2023 | 31 | 0 |
| 2024 | 46 | 0 |
| 2025 | 72 | 0 |
| 2026 | 44 | 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? (2)
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 |
|---|---|---|---|
| * | — | Birtcher Model 625 Named without a submission number | |
| * | — | R.A. Fischer UV-9 Therapy Lamp Named without a submission number |
What descends from it? (424)
See all 4242 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?
- Of its descendants, K040062 (Lerner Medical Devices, Inc., 2004) has gone furthest, with 280 descendants of its own.
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 National Biological Corporation Derma-Wand provides photo-therapeutic ultraviolet light. The UVB wand is indicated for dermatologic disorders such as psoriasis and vitiligo. While the UVC wand is indicated for dermatologic disorder in which bactericidal management is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982082: Handisol Wound Healing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982082
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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