510(k) · Cleared
ClearedRevlight Skin Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skincare Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 27, 2005 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) and 7 other predicates after a 273-day review. Its family tree reaches back 9 generations to 1995. 402 later devices descend from it.
- Decided
- Jun 27, 2005
- Review
- 273 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K943450 (1995). 121 ancestors in all, the oldest K800617 (1980). 402 later devices descend from it, 6 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 deviceK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · cites it directly · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
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 deviceK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
Showing 5 of 402 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 402 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
- K060792IllumimedPhotoactif, LLC · 2006 · cites it directly115descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
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) | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +1 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 12 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 21 | 0 |
| 2018 | 19 | 0 |
| 2019 | 13 | 0 |
| 2020 | 24 | 0 |
| 2021 | 26 | 0 |
| 2022 | 31 | 0 |
| 2023 | 28 | 0 |
| 2024 | 47 | 0 |
| 2025 | 69 | 0 |
| 2026 | 45 | 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? (8)
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 |
|---|---|---|---|
| * | K001179 | Super Nova, Acubeam | 2000 |
| * | K030883 | Omnilux BlueSummary page 1…LED Systems Super Nova/Acubeam (KO01 179) OmniLux Blue (K030883) Revive (OmniLux Red) (K030426) ClearLight (K… | 2003 |
| * | K030426 | Omnilux RedSummary page 1…Super Nova/Acubeam (KO01 179) OmniLux Blue (K030883) Revive (OmniLux Red) (K030426) ClearLight (KO 13623) Aurora SR (K022266;K033… | 2003 |
| * | K013623 | Clearlight Phototheraphy System, Model CL 420 | 2002 |
| * | K022266 | Aurora SRSummary page 1…Revive (OmniLux Red) (K030426) ClearLight (KO 13623) Aurora SR (K022266;K033946(supp)) Lovely I (K033946) Soundskin Pho… | 2002 |
| * | K033946 | Lovely SystemSummary page 1…Revive (OmniLux Red) (K030426) ClearLight (KO 13623) Aurora SR (K022266;K033946(supp)) Lovely I (K033946) Soundskin Phototherap… | 2004 |
| * | K040103 | Soundskin Phototherapy System Cleared while this submission was under review Summary page 1…Aurora SR (K022266;K033946(supp)) Lovely I (K033946) Soundskin Phototherapy System (K040103) Massagers Model HM-45 (K9354597) Device Descri… | 2005 |
| * | K935459 | Omron Massager Model HM-45Summary page 1…Soundskin Phototherapy System (K040103) Massagers Model HM-45 (K9354597) Device Description RevLight is a device that utilizes Light Emitting Diodes to provide… | 1994 |
What descends from it? (402)
See all 4026 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 5 companies; a new generation was cleared every 9 months on median.
- 4 of the 121 ancestors have a recall of any class.
- Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 descendants of its own.
- 12 other devices also cite its predicate K001179.
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?
RevLight is intended for use to provide LED light to the body.
Facial massage.
Used with the RevLight, are generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Used with the RevLight, are generally indicated to provide topical heating to promote increased blood flow, for temporary relaxation of muscle and relief of pain.
Used with the RevLight, are generally indicated to provide topical heating to promote increased blood flow, for temporary relaxation of muscle and relief of pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042630: Revlight Skin Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042630
Report an extraction error
Are you the manufacturer?
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