510(k) · Cleared
ClearedIrradiation Aesthetic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongqing Peninsula Medical Technology Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Jan 30, 2018 as substantially equivalent to K163170 (Capillus, LLC, 2017) and 2 other predicates after a 224-day review. Its family tree reaches back 7 generations to 2000. 5 later devices descend from it.
- Decided
- Jan 30, 2018
- Review
- 224 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001179 (2000). 19 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- 3 generations backK113097 Laser HelmetTheradome, Inc. · 2012
- 2 generations backK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- 1 generation backK153618 Capillus202Capillus, LLC · 2016
- This deviceK171835 Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK192552 Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK231321 Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK192627 Laser Hair Growth CapShang FA Biotechnology Co. · 2019
- Descendant · 3 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 ownK261253 Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6…Ziree Co., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K192552Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd. · 2020 · cites it directly2descendants
- K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd. · 2023 · 2 generations on1descendant
- K192627Laser Hair Growth CapShang FA Biotechnology Co. · 2019 · cites it directly1descendant
- 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 · 3 generations on0descendants
- K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…Ziree Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| −3 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| −2 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| −1 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
| 0 (this device) | K171835 | Irradiation Aesthetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | 2018 | — |
| +1 | K192552 | Irradiation Cosmetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +2 | K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023 | — |
| +1 | K192627 | Laser Hair Growth Cap | Shang FA Biotechnology Co. | 2019 | — |
| +3 | 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 | K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7… | Ziree 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 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 5…Predicate Device Information Sponsor: Capillus LLC Classification Name: Infrared Lamp Trade Name: Capillus272, Capillus202, Capillus82 510(K) Number: K153618, K160285, K163170 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: 2 4. Device Descripti… | 2017 |
| * | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Summary page 5…r 23 3. Predicate Device Information Sponsor: Capillus LLC Classification Name: Infrared Lamp Trade Name: Capillus272, Capillus202, Capillus82 510(K) Number: K153618, K160285, K163170 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: 2 4. Device… | 2016 |
| * | K153618 | Capillus202Summary page 5…), Chapter 23 3. Predicate Device Information Sponsor: Capillus LLC Classification Name: Infrared Lamp Trade Name: Capillus272, Capillus202, Capillus82 510(K) Number: K153618, K160285, K163170 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: 2 4.… | 2016 |
What descends from it? (5)
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 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K192552 (Chongqing Peninsula Medical Technology Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K163170.
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?
The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic
alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-
Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171835: Irradiation Aesthetic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171835
Report an extraction error
Are you the manufacturer?
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