510(k) · Cleared
ClearedSLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair Removal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Classy Lady by Mehl of Puerto Rico, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 13, 1997 as substantially equivalent to K910422 (Spectrum Medical Technologies, Inc., 1992) and 1 other predicate after a 286-day review. Its family tree reaches back 1 generation to 1992. 1,499 later devices descend from it.
- Decided
- Mar 13, 1997
- Review
- 286 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910422 (1992). 2 ancestors in all. 1,499 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- This deviceK962109 SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser…Classy Lady by Mehl of Puerto Rico, 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 1,499 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,499 · 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 |
|---|---|---|---|---|---|
| −1 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| 0 (this device) | K962109 | SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… | Classy Lady by Mehl of Puerto Rico, 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 |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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? (2)
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 |
|---|---|---|---|
| * | K910422 | Model RD-1200 Ruby Laser SystemSummary page 1…ndards) devices. From an operational standpoint the Mehl QD Ruby Laser is substantially equivalent to any number of laser devices, including the Spectrum Model RD-1200 (K910422), used in Dermatology practice. They produce the same wavelength, deliver the same energies to the skin, and are constructed of… | 1992 |
| * | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Summary page 1…mponents. With respect to its patented procedure for removing hair, the Mehl QD Ruby Laser is substantially equivalent to the ThermoLase LT-100 Q-Switched Nd:YAG laser (K950019) in that, 1. 2. 3. Both types of lasers are widely used for dermatological applications; Each is based upon the same technolog… | 1995 |
What descends from it? (1,499)
See all 1,4993 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?
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 Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial 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/K962109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962109: SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair Removal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962109
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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