510(k) · Cleared
ClearedLightwave Professional Deluxe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightwave Technologies, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jan 4, 2010 as substantially equivalent to K030883 (Photo Therapeutics Limited, 2003) and 3 other predicates after a 483-day review. Its family tree reaches back 10 generations to 1995. 4 later devices descend from it.
- Decided
- Jan 4, 2010
- Review
- 483 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K943450 (1995). 92 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- This deviceK082586 Lightwave Professional DeluxeLightwave Technologies, LLC · 2010
- Descendant · cites it directly · 0 of its ownK191693 BC-5Reveallux, Corp · 2019
- Descendant · cites it directly · 0 of its ownK142256 Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK131142 Genesis Led WandsGenesis Biosystems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK100628 PlasmaluxlsDaavlin Distributing Co. · 2010
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- This deviceK082586 Lightwave Professional DeluxeLightwave Technologies, LLC · 2010
Most influential descendants
Showing 4 of 4 · See all- K191693BC-5Reveallux, Corp · 2019 · cites it directly0descendants
- K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd. · 2015 · cites it directly0descendants
- K131142Genesis Led WandsGenesis Biosystems, Inc. · 2013 · cites it directly0descendants
- K100628PlasmaluxlsDaavlin Distributing Co. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| 0 (this device) | K082586 | Lightwave Professional Deluxe | Lightwave Technologies, LLC | 2010 | — |
| +1 | K191693 | BC-5 | Reveallux, Corp | 2019 | — |
| +1 | K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Applied Biophotonics, Ltd. | 2015 | — |
| +1 | K131142 | Genesis Led Wands | Genesis Biosystems, Inc. | 2013 | — |
| +1 | K100628 | Plasmaluxls | Daavlin Distributing Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 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 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K030883 | Omnilux BlueSummary page 1…Regiulation: 878.4510, 890.5500 Product Code: GEX, ILY 3. Predicate Devices Photo Therapeutics Ltd. K030883, Omnnilux Revive (K030426), Omnilux Plus (K04331 7), Omnilux Revive and Plus Combination (K05021 6). 4. Device Descript… | 2003 |
| * | K030426 | Omnilux RedSummary page 1…878.4510, 890.5500 Product Code: GEX, ILY 3. Predicate Devices Photo Therapeutics Ltd. K030883, Omnnilux Revive (K030426), Omnilux Plus (K04331 7), Omnilux Revive and Plus Combination (K05021 6). 4. Device Description The LIGHTWAVETM… | 2003 |
| * | K043317 | Omnilux PlusSummary page 1…0 Product Code: GEX, ILY 3. Predicate Devices Photo Therapeutics Ltd. K030883, Omnnilux Revive (K030426), Omnilux Plus (K04331 7), Omnilux Revive and Plus Combination (K05021 6). 4. Device Description The LIGHTWAVETM Professional Deluxe System uses… | 2005 |
| * | K050216 | Omnilux Revive and Omnilux PlusSummary page 1…EX, ILY 3. Predicate Devices Photo Therapeutics Ltd. K030883, Omnnilux Revive (K030426), Omnilux Plus (K04331 7), Omnilux Revive and Plus Combination (K05021 6). 4. Device Description The LIGHTWAVETM Professional Deluxe System uses high-end Light Emitting Diodes (LED's) to… | 2005 |
What descends from it? (4)
4 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 15 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 92 ancestors have a recall of any class.
- Of its descendants, K191693 (Reveallux, Corp, 2019) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K030883.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. The LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and…
Read the full statement (164 words)
The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
The LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
THE LIGHTWAVE Deluxe Infrared Light is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082586: Lightwave Professional Deluxe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082586
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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