510(k) · Cleared
ClearedNutra Stim Hair Laser Comb
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 Jan 8, 2015 as substantially equivalent to K103368 (Lexington International, LLC, 2011) after a 209-day review. Its family tree reaches back 3 generations to 2007. 4 later devices descend from it.
- Decided
- Jan 8, 2015
- Review
- 209 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060305 (2007). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 2 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 1 generation backK103368 Hairmax LasercombLexington International, LLC · 2011
- This deviceK141596 Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 2015
- Descendant · cites it directly · 3 of its ownK183329 Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK213789 Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK252053 VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F…Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd · 2025
- Descendant · 2 generations on · 0 of its ownK202631 iHelmet Laser CombSlinph Technologies Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K183329Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 2019 · cites it directly3descendants
- K213789Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd · 2025 · 3 generations on0descendants
- K202631iHelmet Laser CombSlinph Technologies Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −2 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −1 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| 0 (this device) | K141596 | Nutra Stim Hair Laser Comb | Nutra Luxe MD, LLC | 2015 | — |
| +1 | K183329 | Laser Hair Therapy | Omm Imports, Inc. D/B/A Zero Gravity | 2019 | 1 |
| +2 | K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | 2022 | — |
| +3 | K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025 | — |
| +2 | K202631 | iHelmet Laser Comb | Slinph Technologies Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K103368 | Hairmax LasercombSummary page 4…ct Codes: OAP 3. Predicate Device The Nutra Stim Hair Laser Comb is substantially equivalent to the HairMax Pro 12 LaserComb (K103368) 4. Device Description The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183329 | Laser Hair Therapy | 2019 | 3 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183329 (Omm Imports, Inc. D/B/A Zero Gravity, 2019) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K103368.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and 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/K141596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141596: Nutra Stim Hair Laser Comb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141596
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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