510(k) · Cleared
ClearedFraxel II 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 Mar 29, 2006 as substantially equivalent to K050841 (Reliant Technologies, Inc., 2005) and 3 other predicates after a 50-day review. Its family tree reaches back 9 generations to 1992. 230 later devices descend from it.
- Decided
- Mar 29, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K910422 (1992). 126 ancestors in all, the oldest K820106 (1982). 230 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- This deviceK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- Descendant · cites it directly · 226 of its ownK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- Descendant · 2 generations on · 194 of its ownK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- Descendant · 3 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 · 2 generations on · 161 of its ownK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- This deviceK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 230 · See all- K062303Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007 · cites it directly226descendants
- K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on194descendants
- K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008 · 3 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 · 2 generations on161descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −1 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| 0 (this device) | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| +1 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| +2 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| +3 | 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 | — |
| +2 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
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 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 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? (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 |
|---|---|---|---|
| * | K050841 | Fraxel SR Laser SystemSummary page 1…ative Devices Device Classification: Class II LEGALLY MARKETED PREDICATE DEVICES Name: Fraxel SR Laser System and Accessories 5 10(k) #: K050841 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #:… | 2005 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…d Accessories 5 10(k) #: K050841 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060 DEVICE DESCRIPTION The Fraxel H SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be… | 2002 |
| * | K040617 | Reliant Laser System IISummary page 2…of the Fraxel [I SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System as described in submission K(050841, K042319, K040617 and K031795. CONCLUSION Based on the design, materials, function, intended use and clinical evaluation, the Fraxel II Laser S… | 2004 |
| * | K031795 | Reliant Laser SystemSummary page 2…l [I SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System as described in submission K(050841, K042319, K040617 and K031795. CONCLUSION Based on the design, materials, function, intended use and clinical evaluation, the Fraxel II Laser System and Ac… | 2003 |
| † | K042319 | Reliant Laser II System and Accessories | 2005 |
What descends from it? (230)
See all 2306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062303 | Fraxel II SR Laser System | 2007 | 226 |
| K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | 2007 | 172 |
| K101490 | Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US | 2010 | 28 |
| K070392 | Mosaic Laser System | 2007 | 8 |
| K202884 | SR-1 Skin Treatment System | 2021 | 4 |
| K130459 | Tria Fan System | 2013 | 1 |
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 1.2 years on median.
- 4 of the 126 ancestors have a recall of any class.
- Of its descendants, K062303 (Reliant Technologies, Inc., 2007) has gone furthest, with 226 descendants of its own.
- 7 other devices also cite its predicate K050841.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
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/K060310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060310: Fraxel II SR Laser System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060310
Report an extraction error
Are you the manufacturer?
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