510(k) · Cleared
ClearedFLASH 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emed, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 31, 2002 after an 87-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Oct 31, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK022583 FLASH 1Emed, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- Descendant · 2 generations on · 6 of its ownK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · 4 generations on · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 5 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K051508Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005 · cites it directly8descendants
- K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008 · 2 generations on6descendants
- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · 3 generations on4descendants
- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · 4 generations on2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022583 | FLASH 1 | Emed, Inc. | 2002 | — |
| +1 | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| +2 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +3 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +4 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +5 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | EsteLux Named without a submission number | |
| * | — | ProLite Pulsed Light Systems Named without a submission number | |
| * | — | Spa Touch Named without a submission number | |
| * | — | IPL Quantum SR Named without a submission number |
What descends from it? (10)
3 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, K051508 (General Project S.R.L., 2005) has gone furthest, with 8 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?
This product is intended for dennatological use by physicians for the following:
Removal of unwanted hair in all skin types
Treatment of vascular and benign pigmented lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022583: FLASH 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022583
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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