510(k) · Cleared
ClearedNutraStim Hair Laser Helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nutra Luxe MD, LLC · OAP Laser, Comb, Hair
Cleared on Sep 16, 2016 as substantially equivalent to K132646 (Sunetics International Marketing Group, LLC, 2013) and 1 other predicate after a 184-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Sep 16, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001179 (2000). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 3 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 2 generations backK122950 Laser HelmetTheradome, Inc. · 2013
- 1 generation backK132646 Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC · 2013
- This deviceK160728 NutraStim Hair Laser HelmetNutra Luxe MD, LLC · 2016
- Descendant · cites it directly · 0 of its ownK182501 Hair Laser HeadbandPulsaderm, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K182501Hair Laser HeadbandPulsaderm, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −3 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −2 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| −1 | K132646 | Sunetics Clinical Bio-Stimulation Laser | Sunetics International Marketing Group, LLC | 2013 | — |
| 0 (this device) | K160728 | NutraStim Hair Laser Helmet | Nutra Luxe MD, LLC | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K132646 | Sunetics Clinical Bio-Stimulation LaserSummary page 4…ivalent to the following predicate devices; Device 510(k) Number Manufacturer Sunetics Clinical Laser “G” or K132646 Sunetics International “W2326” Hairmax Laser Comb 82 K142573 Lexingt… | 2013 |
| * | K142573 | HairMax LaserComb, HairMax LaserCombSummary page 4…Manufacturer Sunetics Clinical Laser “G” or K132646 Sunetics International “W2326” Hairmax Laser Comb 82 K142573 Lexington International Reference devices: Device 510(k) Number… | 2014 |
| † | K122950 | Laser Helmet | 2013 |
| † | K091496 | Mep-90 Hair Growth Stimulation System | 2010 |
| † | K151516 | Capillus82 | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182501 | Hair Laser Headband | 2018 | 0 |
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 16 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K182501 (Pulsaderm, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132646.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patters 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 as stated in the FDA summary.
https://510kreport.com/device/K160728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160728: NutraStim Hair Laser Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160728
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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