510(k) · Cleared
ClearedSunetics Clinical Bio-Stimulation Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunetics International Marketing Group, LLC · OAP Laser, Comb, Hair
Cleared on Dec 20, 2013 as substantially equivalent to K091496 (Midwest Rf, LLC, 2010) and 3 other predicates after a 116-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K001179 (2000). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 3 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 2 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 1 generation backK122950 Laser HelmetTheradome, Inc. · 2013
- This deviceK132646 Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC · 2013
- Descendant · cites it directly · 1 of its ownK160728 NutraStim Hair Laser HelmetNutra Luxe MD, LLC · 2016
- Descendant · cites it directly · 0 of its ownK190685 Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK182501 Hair Laser HeadbandPulsaderm, LLC · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −3 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −2 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −1 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| 0 (this device) | K132646 | Sunetics Clinical Bio-Stimulation Laser | Sunetics International Marketing Group, LLC | 2013 | — |
| +1 | K160728 | NutraStim Hair Laser Helmet | Nutra Luxe MD, LLC | 2016 | — |
| +1 | K190685 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019 | — |
| +2 | 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (4)
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 |
|---|---|---|---|
| * | K091496 | Mep-90 Hair Growth Stimulation SystemSummary page 1…90.5500 (Infrared lamp) Classification: Class 11 Predicate Devices: MEP-90 Hair Growth Stimulation System - Midwest RF LLC - K09 1496 igrow 11 Hair Growth System - Apira Science Inc - K122248 Theradome LH80 PRO Laser Helmet - T… | 2010 |
| * | K122248 | Igrow II Hair Growth SystemSummary page 1…Class 11 Predicate Devices: MEP-90 Hair Growth Stimulation System - Midwest RF LLC - K09 1496 igrow 11 Hair Growth System - Apira Science Inc - K122248 Theradome LH80 PRO Laser Helmet - Theradome Inc - K 122950 Theradome Laser Helmet LH80 PRO -… | 2012 |
| * | K122950 | Laser HelmetSummary page 1…Midwest RF LLC - K09 1496 igrow 11 Hair Growth System - Apira Science Inc - K122248 Theradome LH80 PRO Laser Helmet - Theradome Inc - K 122950 Theradome Laser Helmet LH80 PRO - Theradome Inc - KI 113097 Device The Sunetics Clinical Laser (mod… | 2013 |
| * | K113097 | Laser HelmetSummary page 1…Science Inc - K122248 Theradome LH80 PRO Laser Helmet - Theradome Inc - K 122950 Theradome Laser Helmet LH80 PRO - Theradome Inc - KI 113097 Device The Sunetics Clinical Laser (model "0" & model "W2326") is a stationary. Description: non-invasive, low-le… | 2012 |
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)
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 13 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K160728 (Nutra Luxe MD, LLC, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K091496.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Skin Types I to IV.
The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) l-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132646: Sunetics Clinical Bio-Stimulation Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132646
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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