510(k) · Cleared
ClearedEpilaser Normal Mode Ruby Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 5, 1997 as substantially equivalent to K955612 (Spectrum Medical Technologies, Inc., 1996) and 1 other predicate after a 154-day review. Its family tree reaches back 1 generation to 1995. 1,546 later devices descend from it.
- Decided
- Mar 5, 1997
- Review
- 154 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950019 (1995). 2 ancestors in all. 1,546 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- This deviceK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- Descendant · cites it directly · 1,535 of its ownK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- Descendant · 2 generations on · 1,526 of its ownK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 1,509 of its ownK980517 Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc. · 1998
- Descendant · cites it directly · 1,496 of its ownK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- Descendant · cites it directly · 1,494 of its ownK980420 LightsheerPalomar Medical Products, Inc. · 1998
Showing 5 of 1,546 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,546 · See all- K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997 · cites it directly1,535descendants
- K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999 · 2 generations on1,526descendants
- K980517Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc. · 1998 · cites it directly1,509descendants
- K974536Photoderm HR SystemEsc Medical Systems, Ltd. · 1998 · cites it directly1,496descendants
- K980420LightsheerPalomar Medical Products, Inc. · 1998 · cites it directly1,494descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| 0 (this device) | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| +1 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| +2 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| +1 | K980517 | Epilaser Normal Mode Ruby Laser | Palomar Medical Products, Inc. | 1998 | — |
| +1 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| +1 | K980420 | Lightsheer | Palomar Medical Products, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 16 | 0 |
| 2003 | 28 | 0 |
| 2004 | 17 | 0 |
| 2005 | 29 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 52 | 0 |
| 2009 | 39 | 0 |
| 2010 | 38 | 0 |
| 2011 | 39 | 0 |
| 2012 | 38 | 0 |
| 2013 | 56 | 0 |
| 2014 | 61 | 0 |
| 2015 | 54 | 0 |
| 2016 | 70 | 0 |
| 2017 | 71 | 0 |
| 2018 | 64 | 0 |
| 2019 | 55 | 0 |
| 2020 | 62 | 0 |
| 2021 | 79 | 0 |
| 2022 | 114 | 0 |
| 2023 | 109 | 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 |
|---|---|---|---|
| * | K955612 | RD-1200H Normal Mode Ruby Laser SystemSummary page 1…Laser surgical instrument for use in general and plastic surgery and in dermatology (see 21 CFR 878-4810) Product Code: GEX Panel: 79 Epilaserm Normal Mode Ruby Laser (K955612) Thermolase LT-100 Nd:YAG Laser (K950019) The Bpilaserrll Normal Mode Ruby Laser operates at 694.3 nanometers with pulse durati… | 1996 |
| * | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Summary page 1…al and plastic surgery and in dermatology (see 21 CFR 878-4810) Product Code: GEX Panel: 79 Epilaserm Normal Mode Ruby Laser (K955612) Thermolase LT-100 Nd:YAG Laser (K950019) The Bpilaserrll Normal Mode Ruby Laser operates at 694.3 nanometers with pulse durations of 0.2 - 3.0 msec. The energy is deliv… | 1995 |
What descends from it? (1,546)
See all 1,5467 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973324 | Starlight Pulsed Diode Array Laser System | 1997 | 1,535 |
| K980517 | Epilaser Normal Mode Ruby Laser | 1998 | 1,509 |
| K974536 | Photoderm HR System | 1998 | 1,496 |
| K980420 | Lightsheer | 1998 | 1,494 |
| K971193 | Laseaway Long Pulse and Q-Switched Ruby Laser System | 1997 | 39 |
| K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | 2002 | 0 |
| K980160 | Epilaser I Upgrade Kit | 1998 | 0 |
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 Epilaser™ Normal Mode Ruby Laser is intended to effect hair removal of patients with skin types 1 - 4 through selective photothermolysis of hair follicles in dermatology and plastic surgery. This results in a prolonged growth delay.
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/K963947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963947: Epilaser Normal Mode Ruby Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963947
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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