510(k) · Cleared
ClearedVarilite Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corporation · GEX Powered Laser Surgical Instrument
Cleared on Sep 10, 2004 as substantially equivalent to K964074 (Iriderm Div., 1997) and 4 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1994. 75 later devices descend from it.
- Decided
- Sep 10, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K933880 (1994). 9 ancestors in all, the oldest K883541 (1988). 75 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 deviceK041930 Varilite Laser SystemIridex Corporation · 2004
- 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 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · 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) | K041930 | Varilite Laser System | Iridex Corporation | 2004 | — |
| +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 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K964074 | Diolite 532Summary page 1…following table: Name Manufacturer 510(k) # 1)ioLite 532 IRIDEX Corporation K964074 Aura Laserscope K951034 /K024206 Prima KTP Nidek, Inc… | 1997 |
| * | K951034 | Aura Laser SystemSummary page 1…510(k) # 1)ioLite 532 IRIDEX Corporation K964074 Aura Laserscope K951034 /K024206 Prima KTP Nidek, Inc. K973828 Medilas D SkinPulse S Dorn… | 1995 |
| * | K024206 | Aura Isurgical Laser System & AccessoriesSummary page 1…510(k) # 1)ioLite 532 IRIDEX Corporation K964074 Aura Laserscope K951034 /K024206 Prima KTP Nidek, Inc. K973828 Medilas D SkinPulse S Dornier MedTe… | 2003 |
| * | K973828 | Prima KTP Laser SystemSummary page 1…K964074 Aura Laserscope K951034 /K024206 Prima KTP Nidek, Inc. K973828 Medilas D SkinPulse S Dornier MedTech K003993 Page… | 1998 |
| * | K003993 | Dornier Medilas D Skinpulse Laser System (Skinpulse)Summary page 1…K951034 /K024206 Prima KTP Nidek, Inc. K973828 Medilas D SkinPulse S Dornier MedTech K003993 Page 1 Device Description The Varil-ite is a dual wavelength med… | 2001 |
What descends from it? (75)
See all 753 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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K091534 (Lightmed Corp., 2009) has gone furthest, with 72 descendants of its own.
- 7 other devices also cite its predicate K964074.
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 VariLite Laser System is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces. DioLite 532 handnieces. and ScanLite Scanner is indicated for: * the treatment of vascular lesions including: - Telangiectasia - Cherry Angiomas - Leg Veins - Neovascularization - Spider Angiomas - Port Wine Stains - Roscea - Venous Lakes * the treatment of benign pigmented lesions including: - Lentigines - Freckles -…
Read the full statement (176 words)
The VariLite Laser System is intended for use in dermatological applications:
The 532 nm wavelength delivered with VariLite handpieces. DioLite 532 handnieces. and ScanLite Scanner is indicated for:
* the treatment of vascular lesions including:
- Telangiectasia - Cherry Angiomas
- Leg Veins - Neovascularization
- Spider Angiomas - Port Wine Stains
- Roscea - Venous Lakes
* the treatment of benign pigmented lesions including:
- Lentigines - Freckles
- Dernnatosis Papulosis Nigra - Poiklodenna of Civatte
- Caf& au- lait Stains - Melasma
* the treatment of cutaneous lesions including:
- Verruca - Keratoses
- Skin Tags
* the treatment of moderate inflammatory acne vulgaris.
The 940 nm wavelength delivered with VariLite handpieces is indicated for:
* the treatment of vascular lesions including:
- Telangiectasia - Cherry Angiomas
- Leg Veins - Neovascularization
- Spider Angiornas - Port Wine Stains
- Roscea - Venous Lakes
* the treatment of benign pigmented lesions including:
- Lentigines - Freckles
- Dermatosis Papulosis Nigra - Poiklodenna of Civatte
- Caf6- au- lait Stains - Melasma
* hair removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041930: Varilite Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041930
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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