510(k) · Cleared
ClearedSpectraquattro Pulsed Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amjet Distribution, LLC · GEX Powered Laser Surgical Instrument
Cleared on Oct 11, 2005 as substantially equivalent to K030897 (Radiancy (Israel), Ltd., 2003) and 4 other predicates after a 46-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Oct 11, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K910422 (1992). 23 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 4 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 3 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 2 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 1 generation backK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- This deviceK052336 Spectraquattro Pulsed Light SystemAmjet Distribution, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −5 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −3 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −2 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −1 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K052336 | Spectraquattro Pulsed Light System | Amjet Distribution, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (5)
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 |
|---|---|---|---|
| * | K030897 | Skinstation | 2003 |
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 1…21 CFR 878.4810 Legally Marketed Predicate Devices: Radiancy, Inc. SkinStationTM Pulsed Light System (K0_30897. K032205. K051268). Palomar EsteluxTM Pulsed Light System (K020453), CoolTouch, Inc.… | 2003 |
| * | K051268 | Radiance Acne System with Cleartouch Light UnitSummary page 1…8.4810 Legally Marketed Predicate Devices: Radiancy, Inc. SkinStationTM Pulsed Light System (K0_30897. K032205. K051268). Palomar EsteluxTM Pulsed Light System (K020453), CoolTouch, Inc.… | 2005 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…SkinStationTM Pulsed Light System (K0_30897. K032205. K051268). Palomar EsteluxTM Pulsed Light System (K020453), CoolTouch, Inc. PRIMA Pulsed Light Therapy System (K041323).… | 2002 |
| * | K041323 | Pulsed Light Therapy System, Model PrimaSummary page 1…8). Palomar EsteluxTM Pulsed Light System (K020453), CoolTouch, Inc. PRIMA Pulsed Light Therapy System (K041323). 7-1 Description of the SpectraQuattro Pulsed Light System:… | 2004 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 23 ancestors has a recall.
- 9 other devices also cite its predicate K030897.
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 SpectraQuattro TM Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro TM Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris. SpectraQuattro TM comes with a variety of light spectrum filters. These are indicated below…
Read the full statement (106 words)
The SpectraQuattro TM Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro TM Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.
SpectraQuattro TM comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended:
Light Spectrum Filter — Indications
410-1200 — Mild to moderate inflammatory and pustular inflarmnatory acne vulgaris
530-1200 — pigmented lesions
560-1200 — lentigenes
585-1200 — Vascular lesions, rosacea, hemangiomas, leg veins
640-1200 — Hair removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052336: Spectraquattro 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/K052336
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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