510(k) · Cleared
ClearedFraxel II SR Laser System
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 Jan 31, 2007 as substantially equivalent to K060310 (Reliant Technologies, Inc., 2006) and 2 other predicates after a 176-day review. Its family tree reaches back 10 generations to 1992. 226 later devices descend from it.
- Decided
- Jan 31, 2007
- Review
- 176 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K910422 (1992). 127 ancestors in all, the oldest K820106 (1982). 226 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 1 generation backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- This deviceK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- Descendant · cites it directly · 194 of its ownK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- Descendant · 2 generations on · 187 of its ownK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- Descendant · cites it directly · 172 of its ownK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- Descendant · cites it directly · 161 of its ownK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- Descendant · 2 generations on · 158 of its ownK090195 Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 1 generation backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- This deviceK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
Showing 5 of 226 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 226 · See all- K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · cites it directly194descendants
- K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008 · 2 generations on187descendants
- K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007 · cites it directly172descendants
- K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008 · cites it directly161descendants
- K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009 · 2 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −1 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| 0 (this device) | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| +1 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| +2 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| +1 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| +1 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| +2 | K090195 | Palomar LUX1540 Handpiece | Palomar Medical Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 14 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 0 |
| 2021 | 11 | 0 |
| 2022 | 25 | 0 |
| 2023 | 17 | 0 |
| 2024 | 25 | 0 |
| 2025 | 27 | 0 |
| 2026 | 13 | 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? (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 |
|---|---|---|---|
| * | K060310 | Fraxel II SR Laser System and AccessoriesSummary page 1…rative Devices Device Classification: Class II LEGALLY MARKETED PREDICATE DEVICES Name: Fraxel Ii SR Laser System and Accessories 510(k) #: K060310 Name: Fraxel SR Laser System and Accessories 510(k) #: K050841 Name: Lumenis UltraPulse Encore Carbon Diox… | 2006 |
| * | K050841 | Fraxel SR Laser SystemSummary page 1…PREDICATE DEVICES Name: Fraxel Ii SR Laser System and Accessories 510(k) #: K060310 Name: Fraxel SR Laser System and Accessories 510(k) #: K050841 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K02… | 2005 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…em and Accessories 510(k) #: K050841 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060 DEVICE DESCRIPTION The Fraxel ILSR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be… | 2002 |
| † | K053047 | Fraxel SR Laser System | 2006 |
What descends from it? (226)
See all 2266 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 1.2 years on median.
- 4 of the 127 ancestors have a recall of any class.
- Of its descendants, K071051 (Reliant Technologies, Inc., 2007) has gone furthest, with 194 descendants of its own.
- 5 other devices also cite its predicate K060310.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 II SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.'
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062303: Fraxel II SR Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062303
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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