510(k) · Cleared
ClearedDarwin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luvo Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 15, 2021 as substantially equivalent to K203728 (Luvo Medical Technologies, Inc., 2021) and 1 other predicate after a 90-day review. Its family tree reaches back 24 generations to 1995.
- Decided
- Nov 15, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K943450 (1995). 582 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK190678 TempSureCynosure, Inc. · 2019
- 2 generations backK200241 TempSure SystemCynosure, LLC · 2020
- 1 generation backK210129 RF Thermal SystemLuvo Medical Technologies, Inc. · 2021
- This deviceK212607 DarwinLuvo Medical Technologies, Inc. · 2021
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 11 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 10 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 9 generations backK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- 8 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 7 generations backK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
- 6 generations backK132665 Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013
- 5 generations backK171262 TempSureCynosure, Inc. · 2017
- 4 generations backK182365 TempSure SystemCynosure, Inc. · 2018
- 3 generations backK190678 TempSureCynosure, Inc. · 2019
- 2 generations backK200241 TempSure SystemCynosure, LLC · 2020
- 1 generation backK210129 RF Thermal SystemLuvo Medical Technologies, Inc. · 2021
- This deviceK212607 DarwinLuvo Medical Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −11 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −10 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −9 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| −8 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| −7 | K102698 | Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe | Ellman Int'L, Inc. | 2011 | — |
| −6 | K132665 | Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec | Ellman International, Inc. | 2013 | — |
| −5 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
| −4 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
| −3 | K190678 | TempSure | Cynosure, Inc. | 2019 | — |
| −2 | K200241 | TempSure System | Cynosure, LLC | 2020 | — |
| −1 | K210129 | RF Thermal System | Luvo Medical Technologies, Inc. | 2021 | — |
| 0 (this device) | K212607 | Darwin | Luvo Medical Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 10 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 31 | 0 |
| 1996 | 31 | 0 |
| 1997 | 31 | 0 |
| 1998 | 32 | 0 |
| 1999 | 27 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 48 | 0 |
| 2004 | 36 | 0 |
| 2005 | 33 | 0 |
| 2006 | 18 | 0 |
| 2007 | 23 | 0 |
| 2008 | 20 | 0 |
| 2009 | 13 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K203728 | DarwinSummary page 5…GEX, GEI Legally Marketed Predicate Device Name 510K number Product Code Devices: Darwin K203728 GEX, GEI RF Thermal K210129 GEI… | 2021 |
| * | K210129 | RF Thermal SystemSummary page 5…number Product Code Devices: Darwin K203728 GEX, GEI RF Thermal K210129 GEI System Spirit Hair K153718… | 2021 |
| † | K153718 | Spirit Hair Removal laser Family | 2016 |
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 26 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 33 of the 582 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Diode Laser Handpiece is indicated for: The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as long term, stable reduction in the number of hairs re-growing when measured at 6,9, and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin. The IPL Handpiece has various filters to create different wavelengths. The…
Read the full statement (543 words)
The Diode Laser Handpiece is indicated for:
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as long term, stable reduction in the number of hairs re-growing when measured at 6,9, and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin.
The IPL Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication for use:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
The IPL handpiece is indicated for:
Indication for Use for the 430-980nm wavelength * Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. * For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980nm wavelength * Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines. * For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength * Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines. * The removal of unwanted hair to effect stable long-term or permanent hair reduction * For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980nm wavelength * Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. * The removal of unwanted hair to effect stable long-term or permanent hair reduction * For use on Fitzpatrick skin types
Indication for use for the 640-980nm wavelength * Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. * The removal of unwanted hair to effect stable long-term or permanent hair reduction * For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980nm wavelength * The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime * For use on Fitzpatrick skin types (I-V)
RF Microneedling Handpiece
The RF MicroNeedling Handpiece is indicated for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Thermal RF Handpiece
The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212607: Darwin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212607
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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