510(k) · Cleared
ClearedRadiancy Mistral Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiancy (Israel), Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 7, 2008 as substantially equivalent to K052442 (Radiancy (Israel), Ltd., 2006) and 2 other predicates after a 140-day review. Its family tree reaches back 10 generations to 1992. 6 later devices descend from it.
- Decided
- Jan 7, 2008
- Review
- 140 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K910422 (1992). 84 ancestors in all, the oldest K892514 (1990). 6 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 2 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 1 generation backK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- This deviceK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · cites it directly · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK220794 10PLTentech Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK101901 Ipl Therapy SystemBeijing Starlight Science & Technology Development · 2011
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 5 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 4 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 3 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 2 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 1 generation backK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- This deviceK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · cites it directly4descendants
- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · 2 generations on2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 3 generations on1descendant
- K22079410PLTentech Co., Ltd. · 2022 · 3 generations on0descendants
- K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −3 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −2 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| −1 | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| 0 (this device) | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +1 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +2 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +3 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
| +3 | K220794 | 10PL | Tentech Co., Ltd. | 2022 | — |
| +2 | K101901 | Ipl Therapy System | Beijing Starlight Science & Technology Development | 2011 | — |
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 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K052442 | Radiancy Skinstation with Psoriasis Light Unit AssemblySummary page 2…Yavne, Israel Establishment Registration Number: 9616256 Owner/operator number: 9040071 Predicate Devices Radiancy SkinStation System (K052442), General Project's MED FLASH II(K051508) and McCue's Energist Ultra VPL (K060234). Intended Use / Indications for Use The Radia… | 2006 |
| * | K051508 | Med Flash II Intense Pulsed Light System.Summary page 2…tion Number: 9616256 Owner/operator number: 9040071 Predicate Devices Radiancy SkinStation System (K052442), General Project's MED FLASH II(K051508) and McCue's Energist Ultra VPL (K060234). Intended Use / Indications for Use The Radiancy's Mistral® Device is intended to prov… | 2005 |
| * | K060234 | Mccue Energist Ultra VPL Intense Pulse Light SystemSummary page 2…or number: 9040071 Predicate Devices Radiancy SkinStation System (K052442), General Project's MED FLASH II(K051508) and McCue's Energist Ultra VPL (K060234). Intended Use / Indications for Use The Radiancy's Mistral® Device is intended to provide phototherapeutic light and heat energ… | 2006 |
What descends from it? (6)
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 16 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 84 ancestors has a recall of any class.
- Of its descendants, K091664 (Shenzhen Gsd Tech Co., Ltd., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K052442.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Radiancy's Mistral Device is intended to provide phototherapeutic light and heat energy to the body and is generally indicated to treat dermatological conditions. The Mistral is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I - VI, and mild to moderate psoriasis in patients with Fitzpatrick skin types I - VI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072331 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072331: Radiancy Mistral Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072331
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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