510(k) · Cleared
ClearedMedlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Continuum Biomedical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 10, 1999 as substantially equivalent to K973719 (Continuum Biomedical, Inc., 1997) and 1 other predicate after a 162-day review. Its family tree reaches back 2 generations to 1995. 748 later devices descend from it.
- Decided
- Feb 10, 1999
- Review
- 162 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950019 (1995). 748 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 1 generation backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
- This deviceK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
- Descendant · cites it directly · 742 of its ownK022709 Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · 2 generations on · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004
Showing 5 of 748 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 748 · See all- K022709Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003 · cites it directly742descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 2 generations on402descendants
- K041969Aurora DSSyneron Medical, Ltd. · 2004 · 2 generations on302descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −1 | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| 0 (this device) | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser | Continuum Biomedical, Inc. | 1999 | — |
| +1 | K022709 | Medlite Q-Swithced Laser | Continuum Electro-Optics, Inc. | 2003 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +2 | K041969 | Aurora DS | Syneron Medical, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 24 | 0 |
| 2009 | 13 | 0 |
| 2010 | 17 | 0 |
| 2011 | 19 | 0 |
| 2012 | 15 | 0 |
| 2013 | 25 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 35 | 0 |
| 2017 | 33 | 0 |
| 2018 | 32 | 0 |
| 2019 | 23 | 0 |
| 2020 | 43 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 47 | 0 |
| 2024 | 82 | 0 |
| 2025 | 105 | 0 |
| 2026 | 65 | 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 |
|---|---|---|---|
| * | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserSummary page 1…hed Nd:YAG Laser Medical laser system Instrument, surgical, powered, laser 79-GEX 21 CRF 878.48 Medlite™ Q-Switched Nd:YAG Laser, Medlite™ IV Q-Switched Nd:YAG Laser (K973719, SE date 12/23/97) ThermoLase LT-100 Nd:YAG Laser Hair Removal System (K950019, SE Date 04-03-95) For the removal or lightenin… | 1997 |
| * | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Summary page 1…EX 21 CRF 878.48 Medlite™ Q-Switched Nd:YAG Laser, Medlite™ IV Q-Switched Nd:YAG Laser (K973719, SE date 12/23/97) ThermoLase LT-100 Nd:YAG Laser Hair Removal System (K950019, SE Date 04-03-95) For the removal or lightening of unwanted hair without adjuvant preparation Equivalent None Clinical data… | 1995 |
What descends from it? (748)
See all 7485 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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022709 (Continuum Electro-Optics, Inc., 2003) has gone furthest, with 742 descendants of its own.
- 1 other device also cites its predicate K973719.
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?
For the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.
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/K983054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983054: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983054
Report an extraction error
Are you the manufacturer?
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