510(k) · Cleared
ClearedAesthera Photopneumatic (PPX) 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 Sep 7, 2006 as substantially equivalent to K041554 (Aesthera Corporation, 2005) and 6 other predicates after a 49-day review. Its family tree reaches back 10 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 7, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K910422 (1992). 80 ancestors in all, the oldest K892514 (1990). 4 later devices descend from it, 1 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 backK052442 Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd. · 2006
- This deviceK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- Descendant · cites it directly · 3 of its ownK083730 IsolazAesthera Corporation · 2009
- Descendant · 2 generations on · 1 of its ownK101415 TheraclearTheravant Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK123889 Acleara, TheraclearTheravant Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK121515 Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc. · 2012
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 backK052442 Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd. · 2006
- This deviceK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
Most influential descendants
Showing 4 of 4 · See all- K083730IsolazAesthera Corporation · 2009 · cites it directly3descendants
- K101415TheraclearTheravant Corporation · 2010 · 2 generations on1descendant
- K123889Acleara, TheraclearTheravant Corporation · 2013 · 3 generations on0descendants
- K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc. · 2012 · 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 | K052442 | Radiancy Skinstation with Psoriasis Light Unit Assembly | Radiancy (Israel), Ltd. | 2006 | — |
| 0 (this device) | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| +1 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
| +2 | K101415 | Theraclear | Theravant Corporation | 2010 | — |
| +3 | K123889 | Acleara, Theraclear | Theravant Corporation | 2013 | — |
| +2 | K121515 | Isolaz 2 Intense Pulsed Light System | Solta Medical, Inc. | 2012 | — |
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 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K041554 | Aip Intense Pulsed Light SystemSummary page 1…mary Classification Names: Accessory for, Laser Powered Surgical Instruments III. Predicate Devices • Aesthera AIP Intense Pulsed Light System (K04 1554); * Radiancy Acne System with ClearTouch Light Unit Assembly (KO5 1268); * Radiancy Skin Station with Modif… | 2005 |
| * | K051268 | Radiance Acne System with Cleartouch Light Unit | 2005 |
| * | K052442 | Radiancy Skinstation with Psoriasis Light Unit AssemblySummary page 1…ancy Acne System with ClearTouch Light Unit Assembly (KO5 1268); * Radiancy Skin Station with Modified Light Unit Assembly for Psoriasis System (K052442); * Radiancy ClearTouch Lite Acne Clearance System (K06041 1); * Palomar LuxV Pulsed Light Handpiece for St… | 2006 |
| * | K060411 | Radiancy Cleartouch Lite Acne Clearance SystemSummary page 1…* Radiancy Skin Station with Modified Light Unit Assembly for Psoriasis System (K052442); * Radiancy ClearTouch Lite Acne Clearance System (K06041 1); * Palomar LuxV Pulsed Light Handpiece for StarLux Systems (K04008 1); * Palomar StarLux Pulsed Light Syste… | 2006 |
| * | K040081 | Palomar Luxv HandpieceSummary page 1…em (K052442); * Radiancy ClearTouch Lite Acne Clearance System (K06041 1); * Palomar LuxV Pulsed Light Handpiece for StarLux Systems (K04008 1); * Palomar StarLux Pulsed Light System (K041086); * Novalis Clareon & Solarus Pulsed Light Systems w/ AR Han… | 2004 |
| * | K041086 | Palomar Starlux Pulsed Light SystemSummary page 1…Lite Acne Clearance System (K06041 1); * Palomar LuxV Pulsed Light Handpiece for StarLux Systems (K04008 1); * Palomar StarLux Pulsed Light System (K041086); * Novalis Clareon & Solarus Pulsed Light Systems w/ AR Handpiece (K0433 19) IV. Product Description… | 2005 |
| * | K043319 | Clareon and Solarus Pulsed Light Devices and AccessoriesSummary page 1…ce for StarLux Systems (K04008 1); * Palomar StarLux Pulsed Light System (K041086); * Novalis Clareon & Solarus Pulsed Light Systems w/ AR Handpiece (K0433 19) IV. Product Description The Aesthera PhotopneumatiCTM (PPXTM) System is comprised of the followi… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083730 | Isolaz | 2009 | 3 |
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 9 companies; a new generation was cleared every 10 months on median.
- 1 of the 80 ancestors has a recall of any class.
- Of its descendants, K083730 (Aesthera Corporation, 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K041554.
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 Aesthera Photopneumatic TM (PPxTM) System is intended for:
* The treatment of benign vascular and pigmented lesions;
• Permanent hair reduction;
* The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris).
The Aesthera PhotopneumaticTM (PPXTM) 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/K062048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062048: Aesthera Photopneumatic (PPX) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062048
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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