510(k) Report

510(k) · Cleared

Cleared

Iskra Medical Green Irf Prestige

K083590510(k) TraditionalCleared Apr 17, 2009134-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Iskra Medical, D.O.O. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 17, 2009 as substantially equivalent to K070004 (Alma Lasers, Ltd., 2007) and 5 other predicates after a 134-day review. Its family tree reaches back 15 generations to 1995. 13 later devices descend from it.

Decided
Apr 17, 2009
Review
134 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
6

Its longest line of descent runs back 15 generations to K943450 (1995). 88 ancestors in all, the oldest K800617 (1980). 13 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 2 other ancestors2000: 8 other ancestors2003: 3 other ancestors1999: 4 other ancestors1996: 10 other ancestors1994: 2 other ancestors2002: 8 other ancestors2001: 5 other ancestors1998: 6 other ancestors1997: 13 other ancestors1980: 1 other ancestor1995: 4 other ancestors1992: 3 other ancestors1990: 1 other ancestor1993: 1 other ancestor1985: 1 other ancestor2009: 1 descendant cleared2013: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2022: 1 descendant cleared2015: 1 descendant cleared2026: 3 descendants cleared2024: 3 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005×2: 2 generations cleared close together, K070004 (2007), K072699 (2007) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 6 other ancestors4 generations back: 20 other ancestors5 generations back: 21 other ancestors6 generations back: 12 other ancestors7 generations back: 8 other ancestors8 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K072699 · Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL · Alma Lasers, Ltd. · 2007K070004 · Accent · Alma Lasers, Ltd. · 2007K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50+5
  1. Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 11 generations between
  3. 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
  4. 2 generations backK070004 AccentAlma Lasers, Ltd. · 2007
  5. 1 generation backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
  6. This deviceK083590 Iskra Medical Green Irf PrestigeIskra Medical, D.O.O. · 2009
  7. Descendant · cites it directly · 12 of its ownK092191 Exilis, Model 5000Btl Industries, Ltd. · 2009
  8. Descendant · 2 generations on · 8 of its ownK193201 BTL-785FBtl · 2020
  9. Descendant · 2 generations on · 7 of its ownK211639 BTL-785WBTL Industries, Inc. · 2022
  10. Descendant · 2 generations on · 5 of its ownK222556 BTL-785XBTL Industries, Inc. · 2023
  11. Descendant · 3 generations on · 3 of its ownK233604 BTL-785SBTL Industries, Inc. · 2024
Show all 15 generations
  1. Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
  14. 2 generations backK070004 AccentAlma Lasers, Ltd. · 2007
  15. 1 generation backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
  16. This deviceK083590 Iskra Medical Green Irf PrestigeIskra Medical, D.O.O. · 2009

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009: 12013: 12015: 12020: 22022: 12023: 12024: 32026: 3
2009high 3 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 13 · See all
  • K092191Exilis, Model 5000Btl Industries, Ltd. · 2009 · cites it directly12descendants
  • K193201BTL-785FBtl · 2020 · 2 generations on8descendants
  • K211639BTL-785WBTL Industries, Inc. · 2022 · 2 generations on7descendants
  • K222556BTL-785XBTL Industries, Inc. · 2023 · 2 generations on5descendants
  • K233604BTL-785SBTL Industries, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−14K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−13K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−12K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−11K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−10K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−9K000944Thermage Thermacool SystemThermage, Inc.2000—
−8K013034Modification to: Thermacool IiaThermage, Inc.2001—
−7K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−6K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−5K030142Thermacool TC SystemThermage, Inc.2003—
−4K031671Polaris WRSyneron Medical, Ltd.2003—
−3K051214Aluma Skin Renewal SystemLumenis, Inc.2005—
−2K070004AccentAlma Lasers, Ltd.2007—
−1K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent…Alma Lasers, Ltd.2007—
0 (this device)K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.2009—
+1K092191Exilis, Model 5000Btl Industries, Ltd.2009—
+2K193201BTL-785FBtl2020—
+2K211639BTL-785WBTL Industries, Inc.2022—
+2K222556BTL-785XBTL Industries, Inc.2023—
+3K233604BTL-785SBTL Industries, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199010
199230
199310
199420
199540
1996100
1997130
199860
199940
200080
200150
200280
200330
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201510
202020
202210
202310
202430
202630
FIG. 1 — Lineage of K083590, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K070004Accent
Summary page 1
…al Cutting and Coagulation and Accessories (21 CFR 878.4400) III. Legally Marketed Predicate Devices * Alma Laser Accent RF System (K070004, K072699) • Thermage ThermaCool TC system (K033942, K040135, K053365) * Lumenis Aluma Skin Renewal system (K051214)…
Alma Lasers, Ltd.2007—
*K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL
Summary page 1
…g and Coagulation and Accessories (21 CFR 878.4400) III. Legally Marketed Predicate Devices * Alma Laser Accent RF System (K070004, K072699) • Thermage ThermaCool TC system (K033942, K040135, K053365) * Lumenis Aluma Skin Renewal system (K051214) IV. Devic…
Alma Lasers, Ltd.2007—
*K033942Thermage Thermacool System
Summary page 1
…and Accessories (21 CFR 878.4400) III. Legally Marketed Predicate Devices * Alma Laser Accent RF System (K070004, K072699) • Thermage ThermaCool TC system (K033942, K040135, K053365) * Lumenis Aluma Skin Renewal system (K051214) IV. Device Description The Iskra Medical Green IRF Prest…
Thermage, Inc.2004—
*K040135Thermage Thermacool System
Summary page 1
…ssories (21 CFR 878.4400) III. Legally Marketed Predicate Devices * Alma Laser Accent RF System (K070004, K072699) • Thermage ThermaCool TC system (K033942, K040135, K053365) * Lumenis Aluma Skin Renewal system (K051214) IV. Device Description The Iskra Medical Green IRF Prestige syste…
Thermage, Inc.2004—
*K053365Modification to Thermage Thermacool System
Summary page 1
…21 CFR 878.4400) III. Legally Marketed Predicate Devices * Alma Laser Accent RF System (K070004, K072699) • Thermage ThermaCool TC system (K033942, K040135, K053365) * Lumenis Aluma Skin Renewal system (K051214) IV. Device Description The Iskra Medical Green IRF Prestige system consist…
Thermage, Inc.2005—
*K051214Aluma Skin Renewal System
Summary page 1
…Devices * Alma Laser Accent RF System (K070004, K072699) • Thermage ThermaCool TC system (K033942, K040135, K053365) * Lumenis Aluma Skin Renewal system (K051214) IV. Device Description The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics control…
Lumenis, Inc.2005—

Also cleared against K070004: 11 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092191Exilis, Model 5000Btl Industries, Ltd.200912

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 14 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 3 of the 88 ancestors have a recall of any class.
  • Of its descendants, K092191 (Btl Industries, Ltd., 2009) has gone furthest, with 12 descendants of its own.
  • 11 other devices also cite its predicate K070004.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.

Indications for use as stated in the FDA summary.

Also cleared against K070004

11 other devices cite the same predicate.

  • K192621Medical RFTriworks Group Srl · 2020
  • K133405MinnieElettronica Valseriana Srl · 2014
  • K132431Thermage CPT SystemSolta Medical, Inc. · 20131 recall
  • K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
  • K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc. · 2011
  • K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010

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The GEI category page

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https://510kreport.com/device/K083590 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083590: Iskra Medical Green Irf Prestige.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083590

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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