510(k) · Cleared
ClearedFacial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Jianchao Intelligent Technology Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jan 30, 2026 as substantially equivalent to K241718 (Shenzhen Aozemei Technology Co., Ltd., 2024) and 2 other predicates after a 60-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Jan 30, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K943450 (1995). 184 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 2 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 1 generation backK241718 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- This deviceK253833 Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 14 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 13 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 12 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 11 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 10 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 9 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 8 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 7 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 6 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 5 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 4 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 3 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 2 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 1 generation backK241718 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- This deviceK253833 Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −14 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −13 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −12 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −11 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −10 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −9 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −8 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −7 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −6 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −5 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −4 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −3 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| −2 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| −1 | K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003… | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 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 |
|---|---|---|---|
| * | K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Summary page 5…code Micro-current Facial Beauty Device Shenzhen Aozemei K241718 OHS, OLP Model: AM-810B, AM-810W, Technology Co. Ltd AM-812B, AM-812W 2 Face / Face Evolu… | 2024 |
| * | K171821 | 2 Face / Face EvolutionSummary page 5…OHS, OLP Model: AM-810B, AM-810W, Technology Co. Ltd AM-812B, AM-812W 2 Face / Face Evolution Heat In A Click K171821 NFO, OHS, OLP Infrared Red Blue LED Light Heat Beauty Machine Marci Beauty Inc K2… | 2018 |
| * | K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Summary page 5…Heat In A Click K171821 NFO, OHS, OLP Infrared Red Blue LED Light Heat Beauty Machine Marci Beauty Inc K210545 OHS, OLP Model: Vega; Jupiter; Neptune Reference device:… | 2022 |
| † | K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15… | 2025 |
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 31 years and passes through 14 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 184 ancestors have a recall of any class.
- 6 other devices also cite its predicate K241718.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808: Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. (1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation. (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to…
Read the full statement (122 words)
Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
(1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
(2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
(1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation;
(2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253833: Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253833
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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