510(k) · Cleared
ClearedAlma TED+ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · OAP Laser, Comb, Hair
Cleared on Jun 5, 2026 as substantially equivalent to K230134 (Hubei Yjt Technology Co.,Ltd, 2023) after a 368-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Jun 5, 2026
- Review
- 368 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K060305 (2007). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK230134 Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002Hubei Yjt Technology Co.,Ltd · 2023
- This deviceK251684 Alma TED+ SystemAlma Lasers, Inc. · 2026
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 | K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd | 2023 | — |
| 0 (this device) | K251684 | Alma TED+ System | Alma Lasers, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002Summary page 5…00 Product Code: OAP, OUG Predicate Device / Reference Device(s) Predicate: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 (K230134) (Product Code(s): OAP, ISA Reference: The Alma Soprano Titanium, K230371 (Product Code(s): OUG) Device Description… | 2023 |
| † | K230371 | The Alma Soprano Titanium | 2023 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K230134.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Alma TED+ System is indicated to treat Androgenetic Alopecia and promote hair growth infemales who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick SkinTypers I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251684: Alma TED+ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251684
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026