510(k) · Cleared
ClearedFlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gme German Medical Engineering GmbH · GEX Powered Laser Surgical Instrument
Cleared on Mar 10, 2023 as substantially equivalent to K130193 (Solta Medical, Inc., 2013) and 3 other predicates after a 277-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Mar 10, 2023
- Review
- 277 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K943450 (1995). 277 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- 2 generations backK171702 Exciplex308nmClarteis · 2017
- 1 generation backK191086 ExciplexClarteis · 2019
- This deviceK221623 FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm…Gme German Medical Engineering GmbH · 2023
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 4 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 3 generations backK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- 2 generations backK171702 Exciplex308nmClarteis · 2017
- 1 generation backK191086 ExciplexClarteis · 2019
- This deviceK221623 FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm…Gme German Medical Engineering GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −4 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| −3 | K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 | — |
| −2 | K171702 | Exciplex308nm | Clarteis | 2017 | — |
| −1 | K191086 | Exciplex | Clarteis | 2019 | — |
| 0 (this device) | K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | Gme German Medical Engineering GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 16 | 0 |
| 1996 | 21 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 10 | 0 |
| 2000 | 20 | 0 |
| 2001 | 23 | 0 |
| 2002 | 32 | 0 |
| 2003 | 26 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K130193 | Fraxel Dual 1550/1927 Laser SystemSummary page 4…s II D. Predicate Devices [21 CFR 807.92(a)(3)] The FleySys uses similar technology and physical output characteristics as the following predicate devices: K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System K150752 GME ExSys 308 K171702, K191086 Clarteis Exciplex308nm E.… | 2013 |
| * | K150752 | GME ExSys 308Summary page 4…s uses similar technology and physical output characteristics as the following predicate devices: K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System K150752 GME ExSys 308 K171702, K191086 Clarteis Exciplex308nm E. Device Description [21 CFR 807.92(a)(4)] The device FlexSys cons… | 2015 |
| * | K171702 | Exciplex308nmSummary page 4…and physical output characteristics as the following predicate devices: K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System K150752 GME ExSys 308 K171702, K191086 Clarteis Exciplex308nm E. Device Description [21 CFR 807.92(a)(4)] The device FlexSys consists of a base unit with… | 2017 |
| * | K191086 | ExciplexSummary page 4…ical output characteristics as the following predicate devices: K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System K150752 GME ExSys 308 K171702, K191086 Clarteis Exciplex308nm E. Device Description [21 CFR 807.92(a)(4)] The device FlexSys consists of a base unit with up to two… | 2019 |
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 28 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 14 of the 277 ancestors have a recall of any class.
- 10 other devices also cite its predicate K130193.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies. Modules UVB EPL 308 and UVB EPL 308 lite: The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. Module Infrared 1550: The GME FlexSys System with Infrared 1550 module is indicated for…
Read the full statement (138 words)
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221623: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221623
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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