510(k) · Cleared
ClearedClearlight Phototheraphy System, Model CL 420
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curelight, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 16, 2002 after a 284-day review. The FDA summary names its predicate without a number. 856 later devices descend from it.
- Decided
- Aug 16, 2002
- Review
- 284 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
856 later devices descend from it, 10 citing it directly.
- This deviceK013623 Clearlight Phototheraphy System, Model CL 420Curelight, Ltd. · 2002
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 524 of its ownK030883 Omnilux BluePhoto Therapeutics Limited · 2003
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 403 of its ownK040103 Soundskin Phototherapy SystemBhc International, Ltd. · 2005
- Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
Showing 5 of 856 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 856 · See all- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K030883Omnilux BluePhoto Therapeutics Limited · 2003 · cites it directly524descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K040103Soundskin Phototherapy SystemBhc International, Ltd. · 2005 · cites it directly403descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013623 | Clearlight Phototheraphy System, Model CL 420 | Curelight, Ltd. | 2002 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K030883 | Omnilux Blue | Photo Therapeutics Limited | 2003 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +1 | K040103 | Soundskin Phototherapy System | Bhc International, Ltd. | 2005 | — |
| +1 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 15 | 0 |
| 2008 | 28 | 0 |
| 2009 | 13 | 0 |
| 2010 | 22 | 0 |
| 2011 | 17 | 0 |
| 2012 | 18 | 0 |
| 2013 | 27 | 0 |
| 2014 | 29 | 0 |
| 2015 | 33 | 0 |
| 2016 | 41 | 0 |
| 2017 | 42 | 0 |
| 2018 | 38 | 0 |
| 2019 | 31 | 0 |
| 2020 | 46 | 0 |
| 2021 | 43 | 0 |
| 2022 | 61 | 0 |
| 2023 | 55 | 0 |
| 2024 | 86 | 0 |
| 2025 | 118 | 0 |
| 2026 | 70 | 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 |
|---|---|---|---|
| * | — | Avex Industries, Inc.’s Phototherapeutix Named without a submission number | |
| * | — | National Biological Corporation’s Derma-Wand Named without a submission number | |
| * | — | PhotoMedex, Inc.’s XTrac Excimer Laser System, Model AL 7000 Named without a submission number | |
| * | — | Respironics, Inc.’s Wallaby 3 Phototherapy System Named without a submission number |
What descends from it? (856)
See all 85610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033946 | Lovely System | 2004 | 737 |
| K030883 | Omnilux Blue | 2003 | 524 |
| K040103 | Soundskin Phototherapy System | 2005 | 403 |
| K042630 | Revlight Skin Care System | 2005 | 402 |
| K043329 | Omnilux Revive and Blue | 2005 | 202 |
| K043377 | ZENO | 2005 | 142 |
| K043575 | Dermillume, Model PRO1000 | 2005 | 4 |
| K060567 | Spectragenics Ats-1 | 2006 | 2 |
| K032514 | AC Applicator, Aurora AC | 2004 | 1 |
| K070870 | Skin Care Light | 2007 | 0 |
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?
- Of its descendants, K033946 (Msq (M2), Ltd., 2004) has gone furthest, with 737 descendants of its own.
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 ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013623 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013623: Clearlight Phototheraphy System, Model CL 420.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013623
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026