510(k) · Cleared
ClearedDepilite EL-8B Series Dermo Flash Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hair International Systems USA, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 4, 2006 as substantially equivalent to K043319 (Novalis Medical, LLC, 2004) and 3 other predicates after a 247-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- May 4, 2006
- Review
- 247 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K910422 (1992). 58 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- 1 generation backK043319 Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC · 2004
- This deviceK052371 Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| −1 | K043319 | Clareon and Solarus Pulsed Light Devices and Accessories | Novalis Medical, LLC | 2004 | — |
| 0 (this device) | K052371 | Depilite EL-8B Series Dermo Flash Systems | Hair International Systems USA, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K043319 | Clareon and Solarus Pulsed Light Devices and AccessoriesSummary page 2…Pulsed Light (IPL) Technology: * Clareon TM Pulsed Light System SolarusTM Pulsed Light System Novalis Medical, LLC K043319, Dec. 17, 2004 · ProLite / Plasmalite MPX Pulsed Light System Medical Bio Care Nordic AB… | 2004 |
| * | K023081 | Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Summary page 2…alis Medical, LLC K043319, Dec. 17, 2004 · ProLite / Plasmalite MPX Pulsed Light System Medical Bio Care Nordic AB K023081, Dec. 16, 2002 * Flash I emed, Inc. K022583, Oct. 31, 2002 * EpiLight®… | 2002 |
| * | K022583 | FLASH 1Summary page 2…asmalite MPX Pulsed Light System Medical Bio Care Nordic AB K023081, Dec. 16, 2002 * Flash I emed, Inc. K022583, Oct. 31, 2002 * EpiLight® PhotoDerm®HR ESC Medical Systems, Ltd. K991935, Jan… | 2002 |
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 2…Flash I emed, Inc. K022583, Oct. 31, 2002 * EpiLight® PhotoDerm®HR ESC Medical Systems, Ltd. K991935, January 27, 2000 Section II - Page 2 of 3 510(K) PREMARKET NOTIFICATION Depi… | 2000 |
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.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 58 ancestors has a recall of any class.
- 2 other devices also cite its predicate K043319.
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 Depilite EL-8b DERMO FLASH™ Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH™ Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH™ Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based…
Read the full statement (111 words)
The Depilite EL-8b DERMO FLASH™ Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH™ Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH™ Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052371: Depilite EL-8B Series Dermo Flash Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052371
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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