510(k) · Cleared
ClearedInfrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marci Beauty, Inc. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on May 20, 2022 as substantially equivalent to K203271 (Shenzhen Kaiyan Medical CO, Ltd., 2021) and 3 other predicates after a 449-day review. Its family tree reaches back 15 generations to 1995. 2 later devices descend from it.
- Decided
- May 20, 2022
- Review
- 449 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K943450 (1995). 162 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- 2 generations backK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- 1 generation backK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
- This deviceK210545 Infrared Red blue LED light heat beauty machine, Infrared Red blue…Marci Beauty, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253833 Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243555 LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B…Shenzhen Eyco Technology Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 9 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 8 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 7 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 6 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 5 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 4 generations backK122237 Biophotas LifelightBiophotas, Inc. · 2013
- 3 generations backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- 2 generations backK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- 1 generation backK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
- This deviceK210545 Infrared Red blue LED light heat beauty machine, Infrared Red blue…Marci Beauty, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See all- K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026 · cites it directly0descendants
- K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −9 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −8 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −7 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −6 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −5 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −4 | K122237 | Biophotas Lifelight | Biophotas, Inc. | 2013 | — |
| −3 | K131113 | Biophotas Celluma | Biophotas, Inc. | 2014 | — |
| −2 | K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016 | — |
| −1 | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons… | Ningbo Hesi Electric Co., Ltd. | 2021 | — |
| 0 (this device) | K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light… | Marci Beauty, Inc. | 2022 | — |
| +1 | K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003… | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026 | — |
| +1 | K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B… | Shenzhen Eyco Technology 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 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 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 |
|---|---|---|---|
| * | K203271 | Aduro light therapy Handheld Cleared while this submission was under review Summary page 4…78.4810 Device Class: Class II 3.0 Predicate Device Information Device Name 510K Number Submitter Aduro Light Therapy Handheld K203271 Shenzhen Kaiyan Medical CO LTD LED FACIAL LIGHT THERAPY MASK (Model: K200983 Ningbo… | 2021 |
| * | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin… Cleared while this submission was under review Summary page 4…510K Number Submitter Aduro Light Therapy Handheld K203271 Shenzhen Kaiyan Medical CO LTD LED FACIAL LIGHT THERAPY MASK (Model: K200983 Ningbo Hesi Electric Co., Ltd HK207) Elevare Plus K172909 Omm Imports d/b/a Zer… | 2021 |
| * | K172909 | Elevare, Perfectio 4Summary page 4…hen Kaiyan Medical CO LTD LED FACIAL LIGHT THERAPY MASK (Model: K200983 Ningbo Hesi Electric Co., Ltd HK207) Elevare Plus K172909 Omm Imports d/b/a Zero Gravity Omm Imports, Inc. d/b/a Zero Sapphi… | 2018 |
| * | K172555 | Sapphire, Elevare SapphireSummary page 4…K172909 Omm Imports d/b/a Zero Gravity Omm Imports, Inc. d/b/a Zero Sapphire, Elevare Sapphire K172555 Gravity 4.0 Device Description The proposed device Infrared Red Blue LED Light… | 2018 |
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 27 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 162 ancestors have a recall of any class.
- Of its descendants, K253833 (Shenzhen Jianchao Intelligent Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203271.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
This device is indicated for adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210545: Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210545
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