510(k) · Cleared
ClearedSoundskin Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bhc International, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 18, 2005 as substantially equivalent to K013623 (Curelight, Ltd., 2002) after a 364-day review. Its family tree reaches back 1 generation to 2002. 403 later devices descend from it.
- Decided
- Jan 18, 2005
- Review
- 364 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013623 (2002). 403 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK013623 Clearlight Phototheraphy System, Model CL 420Curelight, Ltd. · 2002
- This deviceK040103 Soundskin Phototherapy SystemBhc International, Ltd. · 2005
- Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 2 generations on · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
Showing 5 of 403 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 403 · See all- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
- K060792IllumimedPhotoactif, LLC · 2006 · 2 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013623 | Clearlight Phototheraphy System, Model CL 420 | Curelight, Ltd. | 2002 | — |
| 0 (this device) | K040103 | Soundskin Phototherapy System | Bhc International, Ltd. | 2005 | — |
| +1 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +2 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K013623 | Clearlight Phototheraphy System, Model CL 420Summary page 1…Instrument, Surgical Powered Product Code: GEX Panel: 79 3. Predicate Devices The Soundskin Phototherapy System is substantially equivalent to the Lumenis Clearlight (K013623) /o (-f ale 3/' 1 H Circuits Ltd… | 2002 |
What descends from it? (403)
See all 4031 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042630 | Revlight Skin Care System | 2005 | 402 |
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?
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 Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
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/K040103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040103: Soundskin Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040103
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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