510(k) · Cleared
ClearedB.Light Clear Evo and B.Light Restore Evo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bemer Int AG · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Sep 23, 2023 as substantially equivalent to K202390 (Shenzhen Kaiyan Medical CO, Ltd., 2021) and 3 other predicates after a 268-day review. Its family tree reaches back 17 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 23, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K943450 (1995). 171 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 2 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 1 generation backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- This deviceK223919 B.Light Clear Evo and B.Light Restore EvoBemer Int AG · 2023
- Descendant · cites it directly · 0 of its ownK252642 Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251825 Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 11 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 10 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 9 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 8 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 7 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 6 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 5 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 4 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 3 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 2 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 1 generation backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- This deviceK223919 B.Light Clear Evo and B.Light Restore EvoBemer Int AG · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −11 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −10 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −9 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −8 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −7 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −6 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −5 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −4 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −3 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −2 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −1 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| 0 (this device) | K223919 | B.Light Clear Evo and B.Light Restore Evo | Bemer Int AG | 2023 | — |
| +1 | K252642 | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025 | — |
| +1 | K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025 | — |
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 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K202390 | Aduro Light Beauty MaskSummary page 4…gy Regulation (21 CFR 878.4810) Product Code: OHS and OLP III Predicate Device: Shenzhen Kaiyan Medical Co. Ltd. (K202390) Common/Usual Name: Aduro Light Beauty Mask Classification Name: Laser Surgical Instrument For Use In… | 2021 |
| * | K210948 | Omnilux CLEARSummary page 4…Dermatology Regulation (21 CFR 878.4810) Product Code: OHS and OLP Secondary Predicate Device: GlobalMed Technologies (K210948) Common/Usual Name: Ominlux CLEAR Classification Name: Laser Surgical Instrument For Use In General A… | 2021 |
| * | K180847 | Neutrogena Light Therapy Acne Mask+Summary page 4…In Dermatology Regulation (21 CFR 878.4810) Product Code: OLP Secondary Predicate Device: Johnson and Johnson Consumer (K180847) Common/Usual Name: Neutrogena Light Therapy Acne Mask+ Classification Name: Laser Surgical Instrumen… | 2018 |
| * | K222377 | Led Mask Platinum MdSummary page 4…rgery And In Dermatology Regulation (21 CFR 878.4810) Product Code: OLP Secondary Predicate Device: Cellreturn Co. Ltd (K222377) Common/Usual Name: LED Mask Platinum MD Classification Name: Laser Surgical Instrument For Use In Ge… | 2022 |
What descends from it? (2)
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 28 years and passes through 12 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 171 ancestors have a recall of any class.
- Of its descendants, K252642 (Shenzhen Dachi Communication Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K202390.
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. 2023, 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?
B.Light Clear Evo:
— The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo:
— Use of light-based treatment to reduce wrinkles on the face.
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/K223919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223919: B.Light Clear Evo and B.Light Restore Evo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223919
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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