510(k) · Cleared
ClearedMedlite IV Q-Switched, Frequency Doubled, 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 Sep 5, 1997 as substantially equivalent to K942622 (Mdi, Inc., 1995) after a 184-day review. Its family tree reaches back 1 generation to 1995. 745 later devices descend from it.
- Decided
- Sep 5, 1997
- Review
- 184 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942622 (1995). 745 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK942622 Laseaway Q-Switched ND:Yag Laser SystemMdi, Inc. · 1995
- This deviceK970808 Medlite IV Q-Switched, Frequency Doubled, ND:Yag LaserContinuum Biomedical, Inc. · 1997
- 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 · 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 745 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 745 · 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 · 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 |
|---|---|---|---|---|---|
| −1 | K942622 | Laseaway Q-Switched ND:Yag Laser System | Mdi, Inc. | 1995 | — |
| 0 (this device) | K970808 | Medlite IV Q-Switched, Frequency Doubled, ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 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 |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 24 | 0 |
| 2009 | 13 | 0 |
| 2010 | 17 | 0 |
| 2011 | 18 | 0 |
| 2012 | 16 | 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? (1)
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 |
|---|---|---|---|
| * | K942622 | Laseaway Q-Switched ND:Yag Laser SystemSummary page 1…itched Nd:YAG Laser System Medical laser system Instrument, surgical, powered, laser 79-GEX 21 CRF 878.48 Polytec PI LaseAway Nd:YAG Laser (Lambda Photometrics, Ltd.) (K942622) Medlite IV™ consists of three main components: the power supply used to provide the proper voltage and current to the laser sys… | 1995 |
What descends from it? (745)
See all 7453 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?
- Its one ancestor has no recall.
- 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?
For incision, exgision, ablation, vaporization in soft tissue
for general dermatelogy - - -
1064nm wavelength: Dark ink (blue, black) tattoo removal
Nevus of Ota
532nm wavelength: Light ink (red) tattoo removal
Vascular lesions
Epidermal pigmented lesions
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/K970808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970808: Medlite IV Q-Switched, Frequency Doubled, 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/K970808
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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