510(k) · Cleared
ClearedIclear Phototherapy System, Model FGCM0002
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 Feb 12, 2003 after a 12-day review. The FDA summary names its predicate without a number. 742 later devices descend from it.
- Decided
- Feb 12, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
742 later devices descend from it, 3 citing it directly.
- This deviceK030338 Iclear Phototherapy System, Model FGCM0002Curelight, Ltd. · 2003
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · 2 generations on · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004
- Descendant · 3 generations on · 301 of its ownK050796 Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005
Showing 5 of 742 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 742 · See all- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 2 generations on402descendants
- K041969Aurora DSSyneron Medical, Ltd. · 2004 · 2 generations on302descendants
- K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on301descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030338 | Iclear Phototherapy System, Model FGCM0002 | Curelight, Ltd. | 2003 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +2 | K041969 | Aurora DS | Syneron Medical, Ltd. | 2004 | — |
| +3 | K050796 | Aurora DS, DS Applicator | Syneron Medical, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 23 | 0 |
| 2009 | 12 | 0 |
| 2010 | 18 | 0 |
| 2011 | 17 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 36 | 0 |
| 2017 | 33 | 0 |
| 2018 | 32 | 0 |
| 2019 | 23 | 0 |
| 2020 | 43 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 47 | 0 |
| 2024 | 82 | 0 |
| 2025 | 105 | 0 |
| 2026 | 65 | 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 |
|---|---|---|---|
| * | — | CureLight Ltd.'s ClearLight Named without a submission number |
What descends from it? (742)
See all 7423 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?
- 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 iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iCZear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030338: Iclear Phototherapy System, Model FGCM0002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030338
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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