510(k) · Cleared
ClearedMed Flash II Intense Pulsed Light System.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Project S.R.L. · GEX Powered Laser Surgical Instrument
Cleared on Oct 5, 2005 as substantially equivalent to K041086 (Palomar Medical Products, Inc., 2005) and 8 other predicates after a 120-day review. Its family tree reaches back 9 generations to 1992. 8 later devices descend from it.
- Decided
- Oct 5, 2005
- Review
- 120 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 9 generations to K910422 (1992). 73 ancestors in all, the oldest K892514 (1990). 8 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 1 generation backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- This deviceK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- Descendant · cites it directly · 6 of its ownK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · 2 generations on · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · 3 generations on · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 4 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK220794 10PLTentech Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 4 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 1 generation backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- This deviceK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008 · cites it directly6descendants
- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · 2 generations on4descendants
- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · 3 generations on2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 4 generations on1descendant
- K22079410PLTentech Co., Ltd. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −2 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −1 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| 0 (this device) | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| +1 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +2 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +3 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +4 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
| +4 | K220794 | 10PL | Tentech Co., Ltd. | 2022 | — |
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 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (9)
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 |
|---|---|---|---|
| * | K041086 | Palomar Starlux Pulsed Light SystemSummary page 1…redicate IDevices The MED flash II Intense Pulsed Light System is substantially equivalent to a combination of the following devices: Palomar's StarLux V (K04 1086, K033549), Palomar's EsteL-ux V (K04008 1), Palomar's EsteLux G (K02094 1), Lumenis' IPL Quantum SR and the Real Ti… | 2005 |
| * | K033549 | Starlux Pulsed Light SystemSummary page 1…The MED flash II Intense Pulsed Light System is substantially equivalent to a combination of the following devices: Palomar's StarLux V (K04 1086, K033549), Palomar's EsteL-ux V (K04008 1), Palomar's EsteLux G (K02094 1), Lumenis' IPL Quantum SR and the Real Time Chiller (K020… | 2004 |
| * | K040081 | Palomar Luxv HandpieceSummary page 1…e Pulsed Light System is substantially equivalent to a combination of the following devices: Palomar's StarLux V (K04 1086, K033549), Palomar's EsteL-ux V (K04008 1), Palomar's EsteLux G (K02094 1), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Cl… | 2004 |
| * | K020941 | Palomar Luxg HandpieceSummary page 1…tially equivalent to a combination of the following devices: Palomar's StarLux V (K04 1086, K033549), Palomar's EsteL-ux V (K04008 1), Palomar's EsteLux G (K02094 1), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K0433… | 2002 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…alomar's StarLux V (K04 1086, K033549), Palomar's EsteL-ux V (K04008 1), Palomar's EsteLux G (K02094 1), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K0433 19). Cutera's Optional Pulsed Light Hand Piece Family (K0500… | 2002 |
| * | K043319 | Clareon and Solarus Pulsed Light Devices and AccessoriesSummary page 1…x V (K04008 1), Palomar's EsteLux G (K02094 1), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K0433 19). Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K04 1095) an… | 2004 |
| * | K050047 | Cutera Optional Pulsed Light Hand Piece FamilySummary page 1…Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K0433 19). Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K04 1095) and General Project's Flash I (K022583). 4. Device Description… | 2005 |
| * | K041095 | Photosilk Pulsed Light SystemSummary page 1…Medical's Clareon Pulsed Light System (K0433 19). Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K04 1095) and General Project's Flash I (K022583). 4. Device Description The MED flash 11 Intense Pulsed Light System is a med… | 2004 |
| * | K022583 | FLASH 1Summary page 1…m (K0433 19). Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K04 1095) and General Project's Flash I (K022583). 4. Device Description The MED flash 11 Intense Pulsed Light System is a medical device emitting light radiat… | 2002 |
What descends from it? (8)
2 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?
- The line of descent spans 13 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 1 of the 73 ancestors has a recall of any class.
- Of its descendants, K072331 (Radiancy (Israel), Ltd., 2008) has gone furthest, with 6 descendants of its own.
- 13 other devices also cite its predicate K041086.
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 MED flash II Intense Pulsed Light System is indicated for use in: * Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction * Treatment of inflammatory acne (acne vulgaris) * Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafd-au-lait * Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas…
Read the full statement (104 words)
The MED flash II Intense Pulsed Light System is indicated for use in:
* Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
* Treatment of inflammatory acne (acne vulgaris)
* Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafd-au-lait
* Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
* The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051508: Med Flash II Intense Pulsed Light System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051508
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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