510(k) · Cleared
ClearedDermalux Tri-Wave MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic Technology, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on May 9, 2020 as substantially equivalent to K190938 (Shanghai Apolo Medical Technology Co., Ltd., 2019) after a 58-day review. Its family tree reaches back 11 generations to 1995. 3 later devices descend from it.
- Decided
- May 9, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K943450 (1995). 93 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK120460 SmartluxMedmix Co., Ltd. · 2012
- 1 generation backK190938 Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- This deviceK200659 Dermalux Tri-Wave MDAesthetic Technology, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK240222 Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK240132 EmoLED (v. 2-USA)Emoled, Srl · 2024
- Descendant · cites it directly · 0 of its ownK233077 FlashHeal 2 (FlashHeal 2.0)Inwound Aps · 2024
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK120460 SmartluxMedmix Co., Ltd. · 2012
- 1 generation backK190938 Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- This deviceK200659 Dermalux Tri-Wave MDAesthetic Technology, Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K120460 | Smartlux | Medmix Co., Ltd. | 2012 | — |
| −1 | K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K200659 | Dermalux Tri-Wave MD | Aesthetic Technology, Ltd. | 2020 | — |
| +1 | K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) | Aesthetic Technology, Ltd. | 2024 | — |
| +1 | K240132 | EmoLED (v. 2-USA) | Emoled, Srl | 2024 | — |
| +1 | K233077 | FlashHeal 2 (FlashHeal 2.0) | Inwound Aps | 2024 | — |
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 |
|---|---|---|
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K190938 | Phototherapy SystemSummary page 4…ery and in Dermatology Regulation Number: 21 CFR §878.4810 Regulatory Class: Class II Product Code: GEX III. PREDICATE DEVICE Phototherapy System; K190938; Shanghai Apolo Medical Technology Co, Ltd. IV. DEVICE DECRIPTION The Dermalux® Tri-Wave MD is a floor standing Class II medica… | 2019 |
What descends from it? (3)
3 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 10 months on median.
- 3 of the 93 ancestors have a recall of any class.
- Of its descendants, K240222 (Aesthetic Technology, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K190938.
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 Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (4l5nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The…
Read the full statement (102 words)
The Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (4l5nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions.
The near-infrared light (830nm wavelength) is generally indicated 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/K200659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200659: Dermalux Tri-Wave MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200659
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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