510(k) · Cleared
ClearedNon-Ablative Wrinkle Treatent Handpiece Modle Pelleve'
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellman Int'L, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 12, 2010 as substantially equivalent to K070004 (Alma Lasers, Ltd., 2007) and 2 other predicates after a 30-day review. Its family tree reaches back 15 generations to 1995. 53 later devices descend from it.
- Decided
- Aug 12, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 92 ancestors in all, the oldest K800617 (1980). 53 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 1 generation backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- This deviceK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- Descendant · cites it directly · 52 of its ownK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- Descendant · cites it directly · 39 of its ownK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
- Descendant · 2 generations on · 17 of its ownK132665 Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013
- Descendant · 2 generations on · 17 of its ownK132431 Thermage CPT SystemSolta Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 16 of its ownK171262 TempSureCynosure, Inc. · 2017
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 1 generation backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- This deviceK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010 · cites it directly52descendants
- K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc. · 2011 · cites it directly39descendants
- K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013 · 2 generations on17descendants
- K132431Thermage CPT SystemSolta Medical, Inc. · 2013 · 2 generations on17descendants
- K171262TempSureCynosure, Inc. · 2017 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −1 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| 0 (this device) | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| +1 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| +1 | K102698 | Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe | Ellman Int'L, Inc. | 2011 | — |
| +2 | K132665 | Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec | Ellman International, Inc. | 2013 | — |
| +2 | K132431 | Thermage CPT System | Solta Medical, Inc. | 2013 | 1 |
| +3 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K070004 | AccentSummary page 2…ational has shown that the dkeaningiand disifectionrmethdcf decribed aboveis ifiar to the cleaning and disinfection method provided with ALMA LASERS ACCENT as cleared by K070004 and ALMA LASERS FAMILY OF ACCENT RE SYSTEMS as cleared by K(072699. Further to this, Ellman International has presented substant… | 2007 |
| * | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLSummary page 3…LASERS LTD:. ACCENT as cleared by K070004 * ALMA LASERS LTD:. ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL as cleared by K072699 * ELLMAN INTERNATIONAL INC Surgitron, Non-Ablative Technique as cleared by K082834 The subject device is substantially equ… | 2007 |
| * | K082834 | Ellman International Non-Ablative Technique for Surgitron IecSummary page 1…urgitron IEC120 4.0 Dual Radio- Frequency generator. The device is considered as an accessory to the RF generator. The generator has been cleared by the FDA under 510(k) K082834 Ellman International Non-Ablative Technique for Surgitron JEC.… | 2009 |
What descends from it? (53)
See all 532 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 15 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 4 of the 92 ancestors have a recall of any class.
- Of its descendants, K102368 (Ellman Int'L, Inc., 2010) has gone furthest, with 52 descendants of its own.
- 11 other devices also cite its predicate K070004.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101967: Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101967
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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