510(k) · Cleared
ClearedFlashHeal 2 (FlashHeal 2.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inwound Aps · GEX Powered Laser Surgical Instrument
Cleared on Jan 18, 2024 as substantially equivalent to K190938 (Shanghai Apolo Medical Technology Co., Ltd., 2019) and 3 other predicates after a 114-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Jan 18, 2024
- Review
- 114 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K943450 (1995). 245 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 2 generations backK200104 OxylightRaja Trading Company, Inc. · 2020
- 1 generation backK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
- This deviceK233077 FlashHeal 2 (FlashHeal 2.0)Inwound Aps · 2024
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 3 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 2 generations backK200104 OxylightRaja Trading Company, Inc. · 2020
- 1 generation backK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
- This deviceK233077 FlashHeal 2 (FlashHeal 2.0)Inwound Aps · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −3 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| −2 | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| −1 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
| 0 (this device) | 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 |
| 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 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K190938 | Phototherapy SystemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Produet Code IK190938 Phototherapy Systems GEX 1 K200659… | 2019 |
| * | K200659 | Dermalux Tri-Wave MDSummary page 5…Produet Code IK190938 Phototherapy Systems GEX 1 K200659 Dermalux Tri-Wave MD GEX 1K221083… | 2020 |
| * | K221083 | Smartlux MiniSummary page 5…GEX 1 K200659 Dermalux Tri-Wave MD GEX 1K221083 Smartlux Mini GEX [K222751… | 2022 |
| * | K222751 | LED Light Therapy Device, KN-7000LSummary page 5…GEX 1K221083 Smartlux Mini GEX [K222751 LED Light Therapy Device, KN-7000L GEX ...--- Device… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 10 of the 245 ancestors have a recall of any class.
- 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. 2024, 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?
FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions. i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions. iii. The infrared…
Read the full statement (154 words)
FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions.
i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions.
iii. The infrared light (850 nm wavelength) is generally used 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.
iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233077: FlashHeal 2 (FlashHeal 2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233077
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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