510(k) · Cleared
ClearedSharplan Ruby Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 7, 1997 as substantially equivalent to K961279 (Sharplan Lasers, Inc., 1996) and 3 other predicates after a 256-day review. Its family tree reaches back 2 generations to 1992. 1,497 later devices descend from it.
- Decided
- Mar 7, 1997
- Review
- 256 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K910422 (1992). 6 ancestors in all, the oldest K892514 (1990). 1,497 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 1 generation backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- This deviceK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- Descendant · cites it directly · 1,496 of its ownK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- Descendant · 2 generations on · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- Descendant · 2 generations on · 1,129 of its ownK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- Descendant · 3 generations on · 1,127 of its ownK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- Descendant · 2 generations on · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
Showing 5 of 1,497 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,497 · See all- K974536Photoderm HR SystemEsc Medical Systems, Ltd. · 1998 · cites it directly1,496descendants
- K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · 2 generations on1,492descendants
- K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002 · 2 generations on1,129descendants
- K022568Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairMedical Bio Care Sweden AB · 2002 · 3 generations on1,127descendants
- K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · 2 generations on1,117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −1 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| 0 (this device) | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| +1 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| +2 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 11 | 0 |
| 2003 | 23 | 0 |
| 2004 | 14 | 0 |
| 2005 | 26 | 0 |
| 2006 | 27 | 0 |
| 2007 | 32 | 0 |
| 2008 | 49 | 0 |
| 2009 | 37 | 0 |
| 2010 | 38 | 0 |
| 2011 | 37 | 0 |
| 2012 | 35 | 0 |
| 2013 | 55 | 0 |
| 2014 | 61 | 0 |
| 2015 | 52 | 0 |
| 2016 | 70 | 0 |
| 2017 | 69 | 0 |
| 2018 | 63 | 0 |
| 2019 | 55 | 0 |
| 2020 | 62 | 0 |
| 2021 | 79 | 0 |
| 2022 | 114 | 0 |
| 2023 | 107 | 0 |
| 2024 | 123 | 0 |
| 2025 | 162 | 0 |
| 2026 | 94 | 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 |
|---|---|---|---|
| * | K961279 | Sharplan Lasers, Inc. Ruby Laser SystemSummary page 1…the following devices: the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair.… | 1996 |
| * | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Summary page 1…wing devices: the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair. Clinical… | 1995 |
| * | K892514 | Ahrs Epilator 629Summary page 1…ces: the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair. Clinical data on 3… | 1990 |
| * | K955612 | RD-1200H Normal Mode Ruby Laser System Cleared while this submission was under review Summary page 1…plan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair. Clinical data on 31 patients wi… | 1996 |
What descends from it? (1,497)
See all 1,4971 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974536 | Photoderm HR System | 1998 | 1,496 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K974536 (Esc Medical Systems, Ltd., 1998) has gone furthest, with 1,496 descendants of its own.
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?
It is intended for use in dermatology for the removal of unwanted dark body hair.
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/K962446 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962446: Sharplan Ruby 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/K962446
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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