510(k) · Cleared
ClearedBiophotas Celluma RESTORE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biophotas, Inc. · OAP Laser, Comb, Hair
Cleared on Jun 29, 2021 as substantially equivalent to K173729 (Photonmd, Inc., 2018) and 1 other predicate after an 83-day review. Its family tree reaches back 9 generations to 2000. 9 later devices descend from it.
- Decided
- Jun 29, 2021
- Review
- 83 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001179 (2000). 23 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations between
- 3 generations backK153618 Capillus202Capillus, LLC · 2016
- 2 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 1 generation backK173729 Revian RedPhotonmd, Inc. · 2018
- This deviceK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
- 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 · 2 of its ownK230597 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. · 2023
- Descendant · 2 generations on · 1 of its ownK253669 Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK262183 Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261675 CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 8 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 7 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 6 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 5 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 4 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 3 generations backK153618 Capillus202Capillus, LLC · 2016
- 2 generations backK162782 iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. · 2017
- 1 generation backK173729 Revian RedPhotonmd, Inc. · 2018
- This deviceK211038 Biophotas Celluma RESTOREBiophotas, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · cites it directly4descendants
- K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. · 2023 · cites it directly2descendants
- K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 2 generations on1descendant
- K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd. · 2026 · 2 generations on0descendants
- K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −8 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −7 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −6 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −5 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −4 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −3 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| −2 | K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017 | — |
| −1 | K173729 | Revian Red | Photonmd, Inc. | 2018 | — |
| 0 (this device) | K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 | — |
| +1 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | 2023 | — |
| +2 | K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model… | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K173729 | Revian RedSummary page 7…K162782 Proposed device. K173729 Significant Property… | 2018 |
| * | K162782 | iHelmet Hair Growth SystemSummary page 7…3 K162782 Proposed device. K173729… | 2017 |
| † | K122237 | Biophotas Lifelight | 2013 |
| † | K131113 | Biophotas Celluma | 2014 |
| † | K152280 | BioPhotas Celluma3 | 2016 |
| † | K171323 | Biophotas CELLUMA3 | 2017 |
What descends from it? (9)
4 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 21 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K242363 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2024) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K173729.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 BioPhotas Celluma RESTORE system is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to -4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - 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/K211038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211038: Biophotas Celluma RESTORE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211038
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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