510(k) · Cleared
ClearedViridis Derma Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · GEX Powered Laser Surgical Instrument
Cleared on Apr 5, 2002 as substantially equivalent to K983020 (Cosmos Medical Technology, 1998) and 5 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1994. 92 later devices descend from it.
- Decided
- Apr 5, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K933880 (1994). 11 ancestors in all, the oldest K883541 (1988). 92 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 2 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 1 generation backK964074 Diolite 532Iriderm Div. · 1997
- This deviceK020071 Viridis Derma LaserQuantel Medical · 2002
- Descendant · cites it directly · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
- Descendant · 2 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- Descendant · 3 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- Descendant · 4 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- Descendant · 5 generations on · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K091534Lightlas Model 532Lightmed Corp. · 2009 · cites it directly72descendants
- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 2 generations on68descendants
- K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 3 generations on46descendants
- K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 4 generations on26descendants
- K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −2 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −1 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| 0 (this device) | K020071 | Viridis Derma Laser | Quantel Medical | 2002 | — |
| +1 | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| +2 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| +3 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| +4 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| +5 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 9 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 9 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 5 | 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? (6)
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 |
|---|---|---|---|
| * | K983020 | Compact KTP LaserSummary page 1…Laifi,er surgical instrument for use in general and plastic surgery and in Name: . dermatology (see: 21 CFR 878.4810). | Pr?djuct Code: GEX Panel: 79 COMPACT KTP Laser (K983020); DioLite 532 Laser System (K964074); Nidek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K0032… | 1998 |
| * | K964074 | Diolite 532Summary page 1…in general and plastic surgery and in Name: . dermatology (see: 21 CFR 878.4810). | Pr?djuct Code: GEX Panel: 79 COMPACT KTP Laser (K983020); DioLite 532 Laser System (K964074); Nidek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K003202) Predicate %le\hcm Tfié Viridis L… | 1997 |
| * | K981447 | Dio-Light 60 Laser SystemSummary page 1…e: . dermatology (see: 21 CFR 878.4810). | Pr?djuct Code: GEX Panel: 79 COMPACT KTP Laser (K983020); DioLite 532 Laser System (K964074); Nidek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K003202) Predicate %le\hcm Tfié Viridis Laser (K001784): Nuvo-Lase 660 Laser System… | 1998 |
| * | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & IISummary page 1…de: GEX Panel: 79 COMPACT KTP Laser (K983020); DioLite 532 Laser System (K964074); Nidek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K003202) Predicate %le\hcm Tfié Viridis Laser (K001784): Nuvo-Lase 660 Laser System (K970667) Device d¢%crfip§ti;c?pn: T\pe Viridis Derma… | 2001 |
| * | K001784 | Viridis LaserSummary page 1…DioLite 532 Laser System (K964074); Nidek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K003202) Predicate %le\hcm Tfié Viridis Laser (K001784): Nuvo-Lase 660 Laser System (K970667) Device d¢%crfip§ti;c?pn: T\pe Viridis Derma frequency doubled Nd:YAG laser emits a beam of… | 2000 |
| * | K970667 | Nuvo-Lase 660 Laser SystemSummary page 1…idek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K003202) Predicate %le\hcm Tfié Viridis Laser (K001784): Nuvo-Lase 660 Laser System (K970667) Device d¢%crfip§ti;c?pn: T\pe Viridis Derma frequency doubled Nd:YAG laser emits a beam of ' coherent light at 532 microns. ===… | 1997 |
What descends from it? (92)
See all 923 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 8 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K091534 (Lightmed Corp., 2009) has gone furthest, with 72 descendants of its own.
- 1 other device also cites its predicate K983020.
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 Viridis Derma laser is intended for photocoagulation of pigmented lesions in dermatology.
These include the following specific applications:
Benign Vascular Lesions Facial Telangiectasias
Port Wine Stains Café au-lait
Erythrosis Benign Pigmented Lesions
Cuperosis Senile Lentigo
Keratoses Hemangiomas (spider and cherry/ strawberry)
Dermatosis Papulosis Nigra (DPN) strawberry)
Leg Telangiectasia - only as a complement to sclerotherapy and for small superficial red vessels
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/K020071 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020071: Viridis Derma Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020071
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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