510(k) · Cleared
ClearedReliant Laser System II
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 Jun 15, 2004 as substantially equivalent to K031795 (Reliant Technologies, Inc., 2003) and 5 other predicates after a 98-day review. Its family tree reaches back 8 generations to 1992. 316 later devices descend from it.
- Decided
- Jun 15, 2004
- Review
- 98 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K910422 (1992). 96 ancestors in all, the oldest K820106 (1982). 316 later devices descend from it, 5 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 backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 1 generation backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- This deviceK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- Descendant · cites it directly · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
- Descendant · 2 generations on · 259 of its ownK061652 Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007
- Descendant · cites it directly · 230 of its ownK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- Descendant · 2 generations on · 226 of its ownK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- Descendant · cites it directly · 195 of its ownK063038 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
Showing 5 of 316 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 316 · See all- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · cites it directly284descendants
- K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007 · 2 generations on259descendants
- K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006 · cites it directly230descendants
- K062303Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007 · 2 generations on226descendants
- K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · cites it directly195descendants
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 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −1 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| 0 (this device) | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| +1 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
| +2 | K061652 | Palomar LUX1540 Handpiece | Palomar Medical Products, Inc. | 2007 | — |
| +1 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| +2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| +1 | K063038 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
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 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 17 | 0 |
| 2019 | 10 | 0 |
| 2020 | 24 | 0 |
| 2021 | 17 | 0 |
| 2022 | 32 | 0 |
| 2023 | 22 | 0 |
| 2024 | 39 | 0 |
| 2025 | 37 | 0 |
| 2026 | 24 | 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 |
|---|---|---|---|
| * | K031795 | Reliant Laser SystemSummary page 1…Laser Surgical Instrument 21 C.F.R § 878.4810 Legally Marketed Predicate Devices: -Reliant Laser System K03 1795 -Altus Medical CoolGuide Lasers w/Pulsed… | 2003 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…er System K03 1795 -Altus Medical CoolGuide Lasers w/Pulsed Light Handpiece K023954 -Aramis 11 Dermatological Laser K023734… | 2003 |
| * | K023734 | Aramis II Dermatological LaserSummary page 1…ide Lasers w/Pulsed Light Handpiece K023954 -Aramis 11 Dermatological Laser K023734 -Candela Smoothbeam Laser System K0… | 2003 |
| * | K030846 | Candela Smoothbeam Laser SystemSummary page 1…-Aramis 11 Dermatological Laser K023734 -Candela Smoothbeam Laser System K030846 -Candela YAG Family of Lasers K03… | 2003 |
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 1…K030846 -Candela YAG Family of Lasers K033 172 -Lumenis Ultrapulse Encore Laser,… | 2003 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…K033 172 -Lumenis Ultrapulse Encore Laser, K022060 Description ofthe Reliant Laser System II: b… | 2002 |
What descends from it? (316)
See all 3165 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 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 96 ancestors have a recall of any class.
- Of its descendants, K042319 (Reliant Technologies, Inc., 2005) has gone furthest, with 284 descendants of its own.
- 5 other devices also cite its predicate K031795.
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 Technologies Laser System II is intended 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) and dyschromia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040617: Reliant Laser System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040617
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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