510(k) · Cleared
ClearedMedlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched 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 Jun 22, 2001 after a 23-day review. The FDA summary names its predicate without a number. 758 later devices descend from it.
- Decided
- Jun 22, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
758 later devices descend from it, 10 citing it directly.
- This deviceK011677 Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3…Continuum Electro-Optics, Inc. · 2001
- 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
- Descendant · 3 generations on · 301 of its ownK050796 Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005
Showing 5 of 758 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 758 · See all- 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
- K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on301descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… | Continuum Electro-Optics, Inc. | 2001 | — |
| +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 | — |
| +3 | K050796 | Aurora DS, DS Applicator | Syneron Medical, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 8 | 0 |
| 2007 | 14 | 0 |
| 2008 | 24 | 0 |
| 2009 | 14 | 0 |
| 2010 | 17 | 0 |
| 2011 | 19 | 0 |
| 2012 | 15 | 0 |
| 2013 | 25 | 0 |
| 2014 | 28 | 0 |
| 2015 | 26 | 0 |
| 2016 | 35 | 0 |
| 2017 | 35 | 0 |
| 2018 | 32 | 0 |
| 2019 | 23 | 0 |
| 2020 | 44 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 47 | 0 |
| 2024 | 82 | 0 |
| 2025 | 107 | 0 |
| 2026 | 66 | 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 |
|---|---|---|---|
| * | — | Medlite™ Q-Switched Nd:YAG Laser Named without a submission number | |
| * | — | Medlite™ IV Q-Switched Nd:YAG Laser Named without a submission number |
What descends from it? (758)
See all 75810 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 |
| K033259 | Light Age Q-Clear Laser, Model 701-1101 | 2004 | 76 |
| K043173 | Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series | 2005 | 39 |
| K083203 | Helios II Q-Switched ND:Yag Laser System | 2009 | 6 |
| K133158 | ND: Yag Laser System | 2014 | 5 |
| K041011 | Ultralight II ND:Yag Laser System | 2004 | 5 |
| K032667 | Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow) | 2004 | 3 |
| K071815 | Noveon, Model LS1100-01-0968 | 2007 | 0 |
| K063072 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems: 532 and 1064 ND:Yag… | 2006 | 0 |
| K061850 | Mini-Yag Laser | 2006 | 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?
- 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
Treatment of Vascular Lesions
Treatment of Pigmented Lesions
Incision, Excision, Ablation, Vaporization of Soft Tissue for
General Dermatology
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/K011677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched 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/K011677
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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