510(k) · Cleared
ClearedHair Laser Headband
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsaderm, LLC · OAP Laser, Comb, Hair
Cleared on Oct 26, 2018 as substantially equivalent to K160728 (Nutra Luxe MD, LLC, 2016) after a 44-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Oct 26, 2018
- Review
- 44 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001179 (2000). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 7 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 6 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 5 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 4 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 3 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 2 generations backK132646 Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC · 2013
- 1 generation backK160728 NutraStim Hair Laser HelmetNutra Luxe MD, LLC · 2016
- This deviceK182501 Hair Laser HeadbandPulsaderm, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −7 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −6 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −5 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −4 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −3 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −2 | K132646 | Sunetics Clinical Bio-Stimulation Laser | Sunetics International Marketing Group, LLC | 2013 | — |
| −1 | K160728 | NutraStim Hair Laser Helmet | Nutra Luxe MD, LLC | 2016 | — |
| 0 (this device) | K182501 | Hair Laser Headband | Pulsaderm, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 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 OAP? 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 OAP device
- #1 K222790 F65 Laser Systemscore 20.5 · 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? (1)
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 |
|---|---|---|---|
| * | K160728 | NutraStim Hair Laser HelmetSummary page 4…ally equivalent to the following predicate devices; Device 510(k) Number Manufacturer NutraStim Hair Laser Helmet K160728 Pulsaderm LLC Page 1 of 4 Device Description… | 2016 |
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.
What does this lineage say?
- The line of descent spans 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OAP
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAP
No recall names OAP since 2007.
Adverse event reports per year · OAP
11in 2025
MAUDE reports naming product code OAP, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 262 | 0 | 1 |
| 2014 | 3 | 80 | 0 | 0 |
| 2015 | 8 | 126 | 0 | 2 |
| 2016 | 8 | 83 | 0 | 1 |
| 2017 | 5 | 83 | 0 | 1 |
| 2018 | 15 | 87 | 0 | 1 |
| 2019 | 9 | 89 | 0 | 4 |
| 2020 | 9 | 88 | 0 | 0 |
| 2021 | 5 | 89 | 0 | 3 |
| 2022 | 8 | 99 | 0 | 2 |
| 2023 | 8 | 81 | 0 | 0 |
| 2024 | 10 | 94 | 0 | 1 |
| 2025 | 6 | 87 | 0 | 11 |
| 2026 | 9 | 83 | 0 | — |
What is it indicated for?
The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood
Hamilton Classifications of 11a to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in
females who have Ludwig (Savin) Scale 1-4, 11-1, 11-2, or frontal, both with Fitzpatrick Skin Types I to IV.
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/K182501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182501: Hair Laser Headband.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182501
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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