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 Jul 5, 2005 as substantially equivalent to K033549 (Palomar Medical Products, Inc., 2004) and 1 other predicate after a 95-day review. Its family tree reaches back 8 generations to 1992. 238 later devices descend from it.
- Decided
- Jul 5, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K910422 (1992). 65 ancestors in all, the oldest K892514 (1990). 238 later devices descend from it, 8 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 3 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 2 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 1 generation backK032460 Profile BBL SystemSciton, Inc · 2003
- This deviceK050841 Fraxel SR Laser SystemReliant Technologies, Inc. · 2005
- Descendant · cites it directly · 230 of its ownK060310 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 · cites it directly · 205 of its ownK053047 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
Showing 5 of 238 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 238 · See all- K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006 · cites it directly230descendants
- K062303Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007 · cites it directly226descendants
- K053047Fraxel SR Laser SystemReliant Technologies, Inc. · 2006 · cites it directly205descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| 0 (this device) | K050841 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2005 | — |
| +1 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| +1 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 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 | 26 | 0 |
| 2023 | 18 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K043219 | FDA’s K043219 is Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems Our reading of the summary gave K043219, FDA’s number for Affinity (Cabinet Name), AC440, HIT440, or the Combination… (Interacoustics AS). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fraxel SR Laser System”. Kept off the family tree. Summary page 1…ation Name: Laser Surgical Instmument 21 C.FR § 878.481 0 Legally Marketed Predicate Devices: Fraxel SR Laser System K043219 Palomar Starlux K033549 Sciton BBL System K032460 Description of the Fraxel SR Las… | 2005 |
| * | K033549 | Starlux Pulsed Light SystemSummary page 1…21 C.FR § 878.481 0 Legally Marketed Predicate Devices: Fraxel SR Laser System K043219 Palomar Starlux K033549 Sciton BBL System K032460 Description of the Fraxel SR Laser System The Fraxel SR Laser System consists… | 2004 |
| * | K032460 | Profile BBL SystemSummary page 1…Marketed Predicate Devices: Fraxel SR Laser System K043219 Palomar Starlux K033549 Sciton BBL System K032460 Description of the Fraxel SR Laser System The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedd… | 2003 |
What descends from it? (238)
See all 2388 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060310 | Fraxel II SR Laser System and Accessories | 2006 | 230 |
| K062303 | Fraxel II SR Laser System | 2007 | 226 |
| K053047 | Fraxel SR Laser System | 2006 | 205 |
| K063038 | Fraxel Iii SR Laser System and Accessories | 2007 | 195 |
| K071051 | Fraxel Iii SR Laser System and Accessories | 2007 | 194 |
| K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | 2007 | 172 |
| K063808 | Fraxel IV SR Laser System | 2007 | 34 |
| 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 13 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 65 ancestors has a recall of any class.
- Of its descendants, K060310 (Reliant Technologies, Inc., 2006) has gone furthest, with 230 descendants of its own.
- 11 other devices also cite its predicate K033549.
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 is intended for use in:
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/K050841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050841: Fraxel SR Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050841
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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