510(k) · Cleared
ClearedRevian Red
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photonmd, Inc. · OAP Laser, Comb, Hair
Cleared on Feb 28, 2018 as substantially equivalent to K162782 (Slinph Technologies Co., Ltd., 2017) and 3 other predicates after an 84-day review. Its family tree reaches back 8 generations to 2000. 19 later devices descend from it.
- Decided
- Feb 28, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K001179 (2000). 22 ancestors in all. 19 later devices descend from it, 9 citing it directly.
- Root · 8 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 7 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 6 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 5 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 4 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 3 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 2 generations backK153618 Capillus202Capillus, LLC · 2016
- 1 generation backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- This deviceK173729 Revian RedPhotonmd, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK193008 Tricoglam Home UseAdvihair S.R.L. · 2020
- Descendant · 2 generations on · 5 of its ownK213025 Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022
- Descendant · cites it directly · 4 of its ownK242363 HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 3 of its ownK230336 CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V. · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K211038Biophotas Celluma RESTOREBiophotas, Inc. · 2021 · cites it directly9descendants
- K193008Tricoglam Home UseAdvihair S.R.L. · 2020 · cites it directly6descendants
- K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd. · 2022 · 2 generations on5descendants
- K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · cites it directly4descendants
- K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V. · 2023 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −7 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −6 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −5 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −4 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −3 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −2 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −1 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| 0 (this device) | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| +1 | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| +1 | K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020 | — |
| +2 | K213025 | Laser hair growth helmet | Kam Yuen Plastic Products, Ltd. | 2022 | — |
| +1 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K230336 | CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) | Light Tree Ventures Europe B.V. | 2023 | — |
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 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K162782 | iHelmet Hair Growth SystemSummary page 4…Device Manufacturer Number iHelmet Hair Growth System K162782 Slinph Technologies HairMD K152019 Trophy Skin… | 2017 |
| * | K152019 | HairMDSummary page 4…Number iHelmet Hair Growth System K162782 Slinph Technologies HairMD K152019 Trophy Skin HairMax LaserComb 82 K142573 Lexington International… | 2015 |
| * | K142573 | HairMax LaserComb, HairMax LaserCombSummary page 4…ystem K162782 Slinph Technologies HairMD K152019 Trophy Skin HairMax LaserComb 82 K142573 Lexington International LH80 PRO K122950 Theradome 1.4 Device Description… | 2014 |
| * | K122950 | Laser HelmetSummary page 4…K152019 Trophy Skin HairMax LaserComb 82 K142573 Lexington International LH80 PRO K122950 Theradome 1.4 Device Description REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopeci… | 2013 |
What descends from it? (19)
See all 199 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211038 | Biophotas Celluma RESTORE | 2021 | 9 |
| K193008 | Tricoglam Home Use | 2020 | 6 |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | 2024 | 4 |
| K230336 | CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) | 2023 | 3 |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | 2025 | 0 |
| K242619 | GroWell BT Hair Growth System (GW10042) | 2024 | 0 |
| K240472 | PBM Hair Therapy Cap | 2024 | 0 |
| K240689 | Robin's Egg | 2024 | 0 |
| K242441 | Revian Lyte (10011) | 2024 | 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 18 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K211038 (Biophotas, Inc., 2021) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K162782.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173729: Revian Red.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173729
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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