510(k) · Cleared
ClearedPhototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Apolo Medical Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 26, 2019 as substantially equivalent to K120460 (Medmix Co., Ltd., 2012) after a 77-day review. Its family tree reaches back 10 generations to 1995. 16 later devices descend from it.
- Decided
- Jun 26, 2019
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K943450 (1995). 92 ancestors in all, the oldest K800617 (1980). 16 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK120460 SmartluxMedmix Co., Ltd. · 2012
- This deviceK190938 Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- 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 · 3 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 · cites it directly · 3 of its ownK200659 Dermalux Tri-Wave MDAesthetic Technology, Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK250761 KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK120460 SmartluxMedmix Co., Ltd. · 2012
- This deviceK190938 Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- 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 · 3 generations on6descendants
- K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd. · 2020 · cites it directly3descendants
- K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K120460 | Smartlux | Medmix Co., Ltd. | 2012 | — |
| 0 (this device) | K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| +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 | — |
| +3 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K200659 | Dermalux Tri-Wave MD | Aesthetic Technology, Ltd. | 2020 | — |
| +4 | K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 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? (1)
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 |
|---|---|---|---|
| * | K120460 | SmartluxSummary page 4…878.4810 Regulatory Class: Class II Product code: GEX Review Panel General & Plastic Surgery III Predicate Devices 510(k) Number: K120460 Trade name: SMARTLUX Common name: Visible and Infrared Light Source Classification: Class II Product Code: G… | 2012 |
What descends from it? (16)
See all 165 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 24 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 92 ancestors have a recall of any class.
- Of its descendants, K222751 (Xuzhou Kernel Medical Equipment Co., Ltd., 2023) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K120460.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Phototherapy Systems use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
The red light (630nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190938 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190938: Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190938
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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