510(k) · Cleared
ClearedReliant Laser II 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 10, 2005 as substantially equivalent to K040617 (Reliant Technologies, Inc., 2004) and 2 other predicates after a 196-day review. Its family tree reaches back 9 generations to 1992. 284 later devices descend from it.
- Decided
- Mar 10, 2005
- Review
- 196 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 97 ancestors in all, the oldest K820106 (1982). 284 later devices descend from it, 5 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 deviceK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
- Descendant · cites it directly · 259 of its ownK061652 Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007
- 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 · cites it directly · 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 deviceK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
Showing 5 of 284 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 284 · See all- K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007 · cites it directly259descendants
- 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
- K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008 · cites it directly161descendants
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) | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
| +1 | K061652 | Palomar LUX1540 Handpiece | Palomar Medical Products, Inc. | 2007 | — |
| +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 | — |
| +1 | 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 | 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 |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 10 | 0 |
| 2018 | 17 | 0 |
| 2019 | 8 | 0 |
| 2020 | 23 | 0 |
| 2021 | 16 | 0 |
| 2022 | 29 | 0 |
| 2023 | 19 | 0 |
| 2024 | 37 | 0 |
| 2025 | 35 | 0 |
| 2026 | 23 | 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 |
|---|---|---|---|
| * | K040617 | Reliant Laser System IISummary page 1…General Surgery/Restorative Dces Dcvice Classification: ' Class i PREDICATE DEVICES Name: Reliant Laser System 1I 510(k) #: K040617 Name: Reliant Laser System 510(k) #: K031795 Name: Lumnnis UltraPulse Encore Carbon… | 2004 |
| * | K031795 | Reliant Laser SystemSummary page 1…Class i PREDICATE DEVICES Name: Reliant Laser System 1I 510(k) #: K040617 Name: Reliant Laser System 510(k) #: K031795 Name: Lumnnis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories… | 2003 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…510(k) #: K031795 Name: Lumnnis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) II: K022060 Reliant Technologies, iunc Pr 'arket Notificynain:… | 2002 |
What descends from it? (284)
See all 2845 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 13 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 4 of the 97 ancestors have a recall of any class.
- Of its descendants, K061652 (Palomar Medical Products, Inc., 2007) has gone furthest, with 259 descendants of its own.
- 4 other devices also cite its predicate K040617.
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) and dyschromia;
Skin resurfacing procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042319: Reliant Laser II System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042319
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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