510(k) · Cleared
ClearedEpildream HP 4000 MED
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D.E.A Project S.R.1. · GEX Powered Laser Surgical Instrument
Cleared on Apr 27, 2023 after a 266-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 27, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
EPILDREAM HP 4000 MED is indicated for: use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. 760 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 808 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 1060 nm wavelength laser is indicated for: • Treatment of pseudofolliculitis barbae…
Read the full statement (143 words)
EPILDREAM HP 4000 MED is indicated for: use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
760 nm wavelength laser is indicated for : Hair removal, permanent hair reduction*
808 nm wavelength laser is indicated for : Hair removal, permanent hair reduction*
1060 nm wavelength laser is indicated for:
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K222352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222352: Epildream HP 4000 MED.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222352
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026