510(k) · Cleared
ClearedFraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliant Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 1, 2008 as substantially equivalent to K063038 (Reliant Technologies, Inc., 2007) and 3 other predicates after a 90-day review. Its family tree reaches back 12 generations to 1992. 187 later devices descend from it.
- Decided
- Jul 1, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K910422 (1992). 149 ancestors in all, the oldest K820106 (1982). 187 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- This deviceK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- Descendant · cites it directly · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- Descendant · 2 generations on · 157 of its ownK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 156 of its ownK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 4 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- This deviceK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
Showing 5 of 187 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 187 · See all- K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · cites it directly158descendants
- K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · 2 generations on157descendants
- K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010 · 2 generations on156descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −3 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −1 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| 0 (this device) | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| +1 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| +2 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| +2 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +4 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 12 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 7 | 0 |
| 2020 | 16 | 0 |
| 2021 | 10 | 0 |
| 2022 | 22 | 0 |
| 2023 | 14 | 0 |
| 2024 | 23 | 0 |
| 2025 | 25 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K063038 | Fraxel Iii SR Laser System and AccessoriesSummary page 1…ice Classification: Class II LEGALLY MARKETED PREDICATE DEVICES Name: Fraxel re:pair (Fraxel III SR) Laser System and Accessories 510(k) #: K063038, K071051 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(… | 2007 |
| * | K071051 | Fraxel Iii SR Laser System and AccessoriesSummary page 1…ification: Class II LEGALLY MARKETED PREDICATE DEVICES Name: Fraxel re:pair (Fraxel III SR) Laser System and Accessories 510(k) #: K063038, K071051 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K02… | 2007 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…cessories 510(k) #: K063038, K071051 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060, K030147 DEVICE DESCRIPTION The Fraxel re:pair Laser System consists of a CO 2 laser source and three delivery handpieces for r… | 2002 |
| * | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersSummary page 1…510(k) #: K063038, K071051 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060, K030147 DEVICE DESCRIPTION The Fraxel re:pair Laser System consists of a CO 2 laser source and three delivery handpieces for resurfacin… | 2003 |
What descends from it? (187)
See all 1873 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 16 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 5 of the 149 ancestors have a recall of any class.
- Of its descendants, K083900 (Palomar Medical Products, Inc., 2009) has gone furthest, with 158 descendants of its own.
- 1 other device also cites its predicate K063038.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in: -Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. -Treatment of wrinkles, rhytides, furrows, fine lines; -Pigmented lesions; -Textural irregularities; -Vascular dyschromia. The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems…
Read the full statement (107 words)
The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:
-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.
The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:
- Actinic and seborrheic keratoses;
-Chelitis;
-Cutaneous horns;
-Hemangiomas;
-Keloids;
-Nevi, including spider, epidermal and protruding;
-Rhinophyma;
-Syringomas;
-Warts;
-Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080915 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080915
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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