510(k) · Cleared
Recalled · Class II · 2022Laser Hair Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omm Imports, Inc. D/B/A Zero Gravity · OAP Laser, Comb, Hair
Cleared on Jan 16, 2019 as substantially equivalent to K142573 (Lexington International, LLC, 2014) and 2 other predicates after a 47-day review. Its family tree reaches back 4 generations to 2007. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2019
- Review
- 47 days
- Class
- Class II
- Product code
- OAP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K060305 (2007). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 3 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 2 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 1 generation backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- This deviceK183329 Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 2019
- Descendant · cites it directly · 1 of its ownK213789 Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. · 2022
- Descendant · 2 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 · cites it directly · 0 of its ownK202631 iHelmet Laser CombSlinph Technologies Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K213789Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. · 2022 · cites it directly1descendant
- K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd · 2025 · 2 generations on0descendants
- K202631iHelmet Laser CombSlinph Technologies Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −3 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −2 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −1 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| 0 (this device) | K183329 | Laser Hair Therapy | Omm Imports, Inc. D/B/A Zero Gravity | 2019 | — |
| +1 | K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | 2022 | — |
| +2 | K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025 | — |
| +1 | K202631 | iHelmet Laser Comb | Slinph Technologies Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K142573 | HairMax LaserComb, HairMax LaserCombSummary page 4…device Applicant Predicate Device 510(k) Number Approval Date Lexington HairMax LaserComb41 K142573 Dec.1, 2014 International, LLC Nutra Stim Hair Laser Comb NutraLuxe MD, LLC… | 2014 |
| * | K141596 | Nutra Stim Hair Laser CombSummary page 4…K142573 Dec.1, 2014 International, LLC Nutra Stim Hair Laser Comb NutraLuxe MD, LLC K141596 Jan.8, 2015 Model NSL-6319 Nutra Stim Hair Laser Comb Nutra… | 2015 |
| * | K141588 | Nutra Stim Hair Laser CombSummary page 4…Jan.8, 2015 Model NSL-6319 Nutra Stim Hair Laser Comb NutraLuxe MD, LLC9 K141588 Jan.8, 2015 Model NSL-6318 2) Reference device: None IV. Device Description… | 2015 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2022 | Class II | Z-1222-2023 | Error in labeling | The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K213789 (Yibin Yingtong Intelligent Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K142573.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183329: Laser Hair Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183329
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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