510(k) · Cleared
ClearedMedlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Continuum Electro-Optics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 17, 2002 after a 22-day review. The FDA summary names its predicate without a number. 784 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
784 later devices descend from it, 14 citing it directly.
- This deviceK014234 Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6…Continuum Electro-Optics, Inc. · 2002
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
- Descendant · cites it directly · 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 784 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 784 · See all- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · cites it directly519descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND… | Continuum Electro-Optics, Inc. | 2002 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 2004 | — |
| +1 | 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 |
|---|---|---|
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 17 | 0 |
| 2011 | 19 | 0 |
| 2012 | 18 | 0 |
| 2013 | 25 | 0 |
| 2014 | 31 | 0 |
| 2015 | 26 | 0 |
| 2016 | 36 | 0 |
| 2017 | 37 | 0 |
| 2018 | 33 | 0 |
| 2019 | 24 | 0 |
| 2020 | 46 | 0 |
| 2021 | 39 | 0 |
| 2022 | 54 | 0 |
| 2023 | 50 | 0 |
| 2024 | 82 | 0 |
| 2025 | 110 | 0 |
| 2026 | 67 | 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 |
|---|---|---|---|
| * | — | Medlite™ IV Q-Switched Nd:YAG Laser Named without a submission number | |
| * | — | Medlite™ Q-Switched Nd:YAG Laser Named without a submission number | |
| * | — | Medlite™ C3 Q-Switched Nd:YAG Laser Named without a submission number |
What descends from it? (784)
See all 78414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033946 | Lovely System | 2004 | 737 |
| K033251 | The Friendlylight ND: Yag Lasers | 2004 | 519 |
| K042000 | Modified MSQ Family of Lovely Light/Laser Systems | 2004 | 517 |
| K063112 | Revlite Q-Switched ND:Yag Laser | 2006 | 169 |
| K053139 | Fotona QX ND:Yag/KTP Laser System | 2006 | 168 |
| K033259 | Light Age Q-Clear Laser, Model 701-1101 | 2004 | 76 |
| K142372 | Pico Way Laser System | 2014 | 70 |
| K083203 | Helios II Q-Switched ND:Yag Laser System | 2009 | 6 |
| K133158 | ND: Yag Laser System | 2014 | 5 |
| K123293 | Pastelle Q-Switched ND: Yag Laser | 2013 | 5 |
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?
- Of its descendants, K033946 (Msq (M2), Ltd., 2004) has gone furthest, with 737 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?
Tattoo Removal
* dark ink: blue and black
e light ink: red
¢ light ink: sky blue
¢ light ink: green
Treatment of Vascular Lesions
e port wine birthmarks
¢ telangiectasias
* spider angioma
e cherry angioma
e spider nevi
Treatment of Pigmented Lesions
e cafe-au-lait birthmarks
solar lentiginos
senile lentiginos
becker’s nevi
freckles
nevus spilus
¢ nevusofota
Incision, Excision, Ablation, Vaporization of Soft Tissue for
General Dermatology
Removal or lightening of unwanted hair with or without adjuvant preparation
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/K014234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014234
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026