510(k) · Cleared
ClearedVersaclear Skin Therapy System, Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theralight, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 20, 2005 as substantially equivalent to K031805 (Dusa Pharmaceuticals, Inc., 2003) and 6 other predicates after a 127-day review. Its family tree reaches back 9 generations to 1995. 47 later devices descend from it.
- Decided
- Sep 20, 2005
- Review
- 127 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K943450 (1995). 90 ancestors in all, the oldest K800617 (1980). 47 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 1 generation backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- This deviceK051259 Versaclear Skin Therapy System, Model 100Theralight, Inc. · 2005
- Descendant · cites it directly · 46 of its ownK090762 LEDAQuantel Derma GmbH · 2009
- Descendant · 2 generations on · 24 of its ownK200104 OxylightRaja Trading Company, Inc. · 2020
- Descendant · 3 generations on · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 3 generations on · 11 of its ownK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
- Descendant · 2 generations on · 9 of its ownK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 1 generation backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- This deviceK051259 Versaclear Skin Therapy System, Model 100Theralight, Inc. · 2005
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K090762LEDAQuantel Derma GmbH · 2009 · cites it directly46descendants
- K200104OxylightRaja Trading Company, Inc. · 2020 · 2 generations on24descendants
- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 3 generations on16descendants
- K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023 · 3 generations on11descendants
- K150752GME ExSys 308Gme (German Medical Engineering) GmbH · 2015 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −1 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| 0 (this device) | K051259 | Versaclear Skin Therapy System, Model 100 | Theralight, Inc. | 2005 | — |
| +1 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| +2 | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| +3 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +3 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
| +2 | K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K031805 | Blu-U, Model 4170Summary page 1…icate Devices: Blu-U Photodynamic Therapy Illuminator Dusa Pharmaceuticals, Inc. K031805 Omnilux Blue Photo Therapeutics, Ltd.… | 2003 |
| * | K030883 | Omnilux BlueSummary page 1…K031805 Omnilux Blue Photo Therapeutics, Ltd. K030883 Omnilux Red Photo Therapeutics, Ltd.… | 2003 |
| * | K030426 | Omnilux RedSummary page 1…K030883 Omnilux Red Photo Therapeutics, Ltd. K030426 Omnilux Revive and Blue Photo Therapeutics, Ltd.… | 2003 |
| * | K043329 | Omnilux Revive and BlueSummary page 1…K030426 Omnilux Revive and Blue Photo Therapeutics, Ltd. K043329 HOUVA II UVA National Biological Corporation… | 2005 |
| * | K885025 | Houva II UvaSummary page 1…K043329 HOUVA II UVA National Biological Corporation K885025 HOUVA 3 Phototherapy System National Biological Corporation… | 1989 |
| * | K041212 | Houva 3 Phototherapy SystemSummary page 1…5025 HOUVA 3 Phototherapy System National Biological Corporation K041212 Page 32 of 35 Predicate… | 2004 |
| * | K841795 | UV 8001K, Puva 800, Puva 180/200 1000Summary page 2…of 35 Predicate Devices (cont'd): UV 1000 Waldmann Lichttechnik K841795 Device Description: The VersaClear T MSkin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or mo… | 1984 |
What descends from it? (47)
See all 471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090762 | LEDA | 2009 | 46 |
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 5 companies; a new generation was cleared every 9 months on median.
- 4 of the 90 ancestors have a recall of any class.
- Of its descendants, K090762 (Quantel Derma GmbH, 2009) has gone furthest, with 46 descendants of its own.
- 5 other devices also cite its predicate K031805.
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 VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light modules for the treatment of moderate inflammatory acne vulgaris, and for use alone the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051259: Versaclear Skin Therapy System, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051259
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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