510(k) · Cleared
ClearedFraxel 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 Mar 20, 2006 as substantially equivalent to K050841 (Reliant Technologies, Inc., 2005) and 5 other predicates after a 143-day review. Its family tree reaches back 9 generations to 1992. 205 later devices descend from it.
- Decided
- Mar 20, 2006
- Review
- 143 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K910422 (1992). 113 ancestors in all, the oldest K822136 (1982). 205 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 1 generation backK050841 Fraxel SR Laser SystemReliant Technologies, Inc. · 2005
- This deviceK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
- Descendant · cites it directly · 195 of its ownK063038 Fraxel Iii SR Laser System and AccessoriesReliant 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 · 3 generations on · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- Descendant · 4 generations on · 157 of its ownK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
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 backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 4 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 1 generation backK050841 Fraxel SR Laser SystemReliant Technologies, Inc. · 2005
- This deviceK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 205 · See all- K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · cites it directly195descendants
- 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
- K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · 3 generations on158descendants
- K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · 4 generations on157descendants
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 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −2 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −1 | K050841 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2005 | — |
| 0 (this device) | K053047 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2006 | — |
| +1 | K063038 | Fraxel Iii SR Laser System and Accessories | 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 | — |
| +3 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| +4 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 13 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 14 | 0 |
| 2019 | 7 | 0 |
| 2020 | 16 | 0 |
| 2021 | 10 | 0 |
| 2022 | 23 | 0 |
| 2023 | 15 | 0 |
| 2024 | 24 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050841 | Fraxel SR Laser SystemSummary page 2…on Name: Laser Surgical Instrument 21 C.F.R § 878.48 10 Legally Marketed Predicate Devices: Fraxel SR Laser System K050841 Candela VBeani K033461 Candela CBeami K033331 Candela Smootl… | 2005 |
| * | K033461 | Candela Vbeam Pulse Dye Laser SystemSummary page 2…21 C.F.R § 878.48 10 Legally Marketed Predicate Devices: Fraxel SR Laser System K050841 Candela VBeani K033461 Candela CBeami K033331 Candela Smootlibearn K041 242 CoolTou… | 2004 |
| * | K033331 | Candela Cbeam Pulse Dye Laser SystemSummary page 2…lly Marketed Predicate Devices: Fraxel SR Laser System K050841 Candela VBeani K033461 Candela CBeami K033331 Candela Smootlibearn K041 242 CoolTouch CT3 K043046 Lurnenis… | 2004 |
| * | K041242 | Candela Smoothbeam Laser SystemSummary page 2…Fraxel SR Laser System K050841 Candela VBeani K033461 Candela CBeami K033331 Candela Smootlibearn K041 242 CoolTouch CT3 K043046 Lurnenis Ufltrapulse Encore K(022060 Description of the Fra… | 2004 |
| * | K043046 | Cooltouch, Model CT3SSummary page 2…Candela VBeani K033461 Candela CBeami K033331 Candela Smootlibearn K041 242 CoolTouch CT3 K043046 Lurnenis Ufltrapulse Encore K(022060 Description of the Fraxel SR Lascr System The Fraxel SR Laser Syst… | 2005 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 2…ela CBeami K033331 Candela Smootlibearn K041 242 CoolTouch CT3 K043046 Lurnenis Ufltrapulse Encore K(022060 Description of the Fraxel SR Lascr System The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embed… | 2002 |
What descends from it? (205)
See all 2054 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 14 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 4 of the 113 ancestors have a recall of any class.
- Of its descendants, K063038 (Reliant Technologies, Inc., 2007) has gone furthest, with 195 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?
The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of surgical scars and acne 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/K053047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053047: Fraxel SR Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053047
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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