510(k) · Cleared
ClearedOxylight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raja Trading Company, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 4, 2020 as substantially equivalent to K122237 (Biophotas, Inc., 2013) and 2 other predicates after a 139-day review. Its family tree reaches back 16 generations to 1995. 24 later devices descend from it.
- Decided
- Jun 4, 2020
- Review
- 139 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 237 ancestors in all, the oldest K800617 (1980). 24 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK090762 LEDAQuantel Derma GmbH · 2009
- This deviceK200104 OxylightRaja Trading Company, Inc. · 2020
- Descendant · cites it directly · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 11 of its ownK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
- Descendant · 2 generations on · 7 of its ownK241293 LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC · 2024
- Descendant · 2 generations on · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 3 of its ownK242593 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK090762 LEDAQuantel Derma GmbH · 2009
- This deviceK200104 OxylightRaja Trading Company, Inc. · 2020
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · cites it directly16descendants
- K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023 · cites it directly11descendants
- K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC · 2024 · 2 generations on7descendants
- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 2 generations on6descendants
- K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −1 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| 0 (this device) | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| +1 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
| +2 | K241293 | LED Light Therapy Device, ELIXIR MD™ | Yassen Wellness, LLC | 2024 | — |
| +2 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +2 | K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F… | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 17 | 0 |
| 1997 | 21 | 0 |
| 1998 | 13 | 0 |
| 1999 | 8 | 0 |
| 2000 | 21 | 0 |
| 2001 | 22 | 0 |
| 2002 | 28 | 0 |
| 2003 | 18 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 13 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K122237 | Biophotas LifelightSummary page 4…Applicable Wellness Legally Marketed Equivalent Devices LED BLUE Light BioPhotas, Inc. BioPhotas LifeLight K122237 – Primary LED BLUE Light Photo Therapeutics Ltd Omnilux Blue K030883 – Reference L… | 2013 |
| * | K030426 | Omnilux RedSummary page 4…utics Ltd Omnilux Blue K030883 – Reference LED RED Light Photo Therapeutics Ltd Omnilux Revive K030426 – Primary LED YELLOW – Quantel Derma GMBH AM LEDA – Applicator K090762 - Primary… | 2003 |
| * | K090762 | LEDASummary page 4…utics Ltd Omnilux Revive K030426 – Primary LED YELLOW – Quantel Derma GMBH AM LEDA – Applicator K090762 - Primary Wolfsmantel 46 SCR 585 DEVICE DESCRIPTION The Oxylight system i… | 2009 |
| † | K030883 | Omnilux Blue | 2003 |
What descends from it? (24)
See all 245 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 25 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 10 of the 237 ancestors have a recall of any class.
- Of its descendants, K240089 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2024) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K122237.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Oxylight is intended for dermatological use by physicians and healthcare professionals for the following:
LED Technology is intended for:
-Blue LED – 465nm – to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
-Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions.
-Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.
Microdermabrasion is intended for exfoliation of the skin.
Oxygen spray is intended to refresh the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200104: Oxylight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200104
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