510(k) · Cleared
ClearedSmartlux Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medmix Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jul 12, 2022 as substantially equivalent to K192755 (Silhouet-Tone Corporation, 2019) after a 90-day review. Its family tree reaches back 13 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 12, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K943450 (1995). 133 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 2 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 1 generation backK192755 Soli-Lite LG4 GalileoSilhouet-Tone Corporation · 2019
- This deviceK221083 Smartlux MiniMedmix Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK233077 FlashHeal 2 (FlashHeal 2.0)Inwound Aps · 2024
- Descendant · cites it directly · 0 of its ownK231894 LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 5 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 4 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 3 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 2 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 1 generation backK192755 Soli-Lite LG4 GalileoSilhouet-Tone Corporation · 2019
- This deviceK221083 Smartlux MiniMedmix Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −5 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −4 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −3 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −2 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −1 | K192755 | Soli-Lite LG4 Galileo | Silhouet-Tone Corporation | 2019 | — |
| 0 (this device) | K221083 | Smartlux Mini | Medmix Co., Ltd. | 2022 | — |
| +1 | K233077 | FlashHeal 2 (FlashHeal 2.0) | Inwound Aps | 2024 | — |
| +1 | K231894 | LED Spectrum therapy instrument | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023 | — |
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 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K192755 | Soli-Lite LG4 GalileoSummary page 5…vice(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; Predicate Device 510(k) Number K192755 Trade/Device/Model Name Soli-Lite LG4 Galileo Product Name Phototherapy Unit De… | 2019 |
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 1.2 years on median.
- 4 of the 133 ancestors have a recall of any class.
- Of its descendants, K233077 (Inwound Aps, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Blue (415-425nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Red (630-640nm) and Infrared (820-830nm) 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. Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum…
Read the full statement (108 words)
Blue (415-425nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (630-640nm) and Infrared (820-830nm) 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.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; 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/K221083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221083: Smartlux Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221083
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