510(k) · Cleared
ClearedAip Intense Pulsed Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthera Corporation · GEX Powered Laser Surgical Instrument
Cleared on Apr 27, 2005 as substantially equivalent to K032205 (Radiancy (Israel), Ltd., 2003) and 8 other predicates after a 321-day review. Its family tree reaches back 6 generations to 1992. 9 later devices descend from it.
- Decided
- Apr 27, 2005
- Review
- 321 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K910422 (1992). 27 ancestors in all, the oldest K892514 (1990). 9 later devices descend from it, 2 citing it directly.
- 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 deviceK041554 Aip Intense Pulsed Light SystemAesthera Corporation · 2005
- Descendant · cites it directly · 4 of its ownK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- Descendant · 2 generations on · 3 of its ownK083730 IsolazAesthera Corporation · 2009
- Descendant · cites it directly · 3 of its ownK062589 Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd. · 2006
- Descendant · 3 generations on · 1 of its ownK101415 TheraclearTheravant Corporation · 2010
- Descendant · 2 generations on · 1 of its ownK071469 Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp. · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006 · cites it directly4descendants
- K083730IsolazAesthera Corporation · 2009 · 2 generations on3descendants
- K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd. · 2006 · cites it directly3descendants
- K101415TheraclearTheravant Corporation · 2010 · 3 generations on1descendant
- K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp. · 2007 · 2 generations on1descendant
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) | K041554 | Aip Intense Pulsed Light System | Aesthera Corporation | 2005 | — |
| +1 | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| +2 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
| +1 | K062589 | Serenity PSF (Pneumatic Skin Flattening) System | Inolase 2002, Ltd. | 2006 | — |
| +3 | K101415 | Theraclear | Theravant Corporation | 2010 | — |
| +2 | K071469 | Inolase Serenity PSF ( Pneumatic Skin Flattening) System | Candela Corp. | 2007 | — |
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 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 1…GEX Predicate Devices: * SkinStation Tm , SPRTm, ClearTouchiTm, SpaTouch Pro (XtremeClear TM, SpaTouch T M (Radiancy (Israel) Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (… | 2003 |
| * | K033181 | SPR SystemSummary page 1…GEX Predicate Devices: * SkinStation Tm , SPRTm, ClearTouchiTm, SpaTouch Pro (XtremeClear TM, SpaTouch T M (Radiancy (Israel) Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K… | 2003 |
| * | K030897 | SkinstationSummary page 1…icate Devices: * SkinStation Tm , SPRTm, ClearTouchiTm, SpaTouch Pro (XtremeClear TM, SpaTouch T M (Radiancy (Israel) Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K0… | 2003 |
| * | K020856 | Spatouch Photoepilation SystemSummary page 1…ices: * SkinStation Tm , SPRTm, ClearTouchiTm, SpaTouch Pro (XtremeClear TM, SpaTouch T M (Radiancy (Israel) Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K020453, K0… | 2002 |
| * | K992482 | Delight II Hair Removal System (the Delight System)Summary page 1…* SkinStation Tm , SPRTm, ClearTouchiTm, SpaTouch Pro (XtremeClear TM, SpaTouch T M (Radiancy (Israel) Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K020453, K010618, K0… | 1999 |
| * | K033549 | Starlux Pulsed Light SystemSummary page 1…adiancy (Israel) Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K020453, K010618, K003886) E-2 Device Description: The A… | 2004 |
| Kept off the family tree | K020943 | FDA’s K020943 is Sterile Disposable Vinyl Exam Gloves, Powder Free Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…Ltd.) (K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K020453, K010618, K003886) E-2 Device Description: The AesThera AIP Inten… | 2002 |
| * | K010618 | Palomar Dermalux Pulsed Light SystemSummary page 1…(K032205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K020453, K010618, K003886) E-2 Device Description: The AesThera AIP Intense Pulsed… | 2001 |
| * | K003886 | Palomar Spalight Pulsed Light SystemSummary page 1…32205, K033 181, K030897, K020856, K992482) * StarLux TM , MediLUXTm, EsteLUXTM (Palomar Medical Technologies, Inc.) (K033549, K02094¾,K020453, K010618, K003886) E-2 Device Description: The AesThera AIP Intense Pulsed Light Sy… | 2001 |
What descends from it? (9)
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 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K062048 (Aesthera Corporation, 2006) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K032205.
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 AlP Intense Pulsed Light System is an intense pulsed light device
intended for the following: the treatment of benign vascular and pigmented
lesions, and permanent hair reduction.
The AlP Intense Pulsed Light System is intended for use on all skin types
(Fitzpatrick skin types I-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041554 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041554: Aip Intense Pulsed Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041554
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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