510(k) · Cleared
ClearedCandela-Inolase Serenity Pro PSF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inolase, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 10, 2008 as substantially equivalent to K071469 (Candela Corp., 2007) and 2 other predicates after an 87-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jan 10, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 53 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK041554 Aip Intense Pulsed Light SystemAesthera Corporation · 2005
- 2 generations backK062589 Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd. · 2006
- 1 generation backK071943 Serenity Pro PSF SystemInolase 2002, Ltd. · 2007
- This deviceK072925 Candela-Inolase Serenity Pro PSF SystemInolase, Ltd. · 2008
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 backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- 3 generations backK041554 Aip Intense Pulsed Light SystemAesthera Corporation · 2005
- 2 generations backK062589 Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd. · 2006
- 1 generation backK071943 Serenity Pro PSF SystemInolase 2002, Ltd. · 2007
- This deviceK072925 Candela-Inolase Serenity Pro PSF SystemInolase, Ltd. · 2008
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 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| −3 | K041554 | Aip Intense Pulsed Light System | Aesthera Corporation | 2005 | — |
| −2 | K062589 | Serenity PSF (Pneumatic Skin Flattening) System | Inolase 2002, Ltd. | 2006 | — |
| −1 | K071943 | Serenity Pro PSF System | Inolase 2002, Ltd. | 2007 | — |
| 0 (this device) | K072925 | Candela-Inolase Serenity Pro PSF System | Inolase, Ltd. | 2008 | — |
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 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K071469 | Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemSummary page 2…mary 7. PerformanceData: The basis for substantial equivalence for this device (K072925) relies upon the clinical data which was submitted in K071469. K071469 was determined to be substantially equivalent by FDA on 8/1512007. This… | 2007 |
| * | K071943 | Serenity Pro PSF SystemSummary page 1…FR 878.481 0- Tradename of device: Serenity Pro PSF TM System 3. Predicate Devices: Inolase Serenity PSF rm (Pneumatic Skin Flattening) Systems (K(071469), (K071943) & (K062589) 4. Description: The Serenity Pro PSF TM System is a device which… | 2007 |
| * | K062589 | Serenity PSF (Pneumatic Skin Flattening) SystemSummary page 1…ro PSF TM System 3. Predicate Devices: Inolase Serenity PSF rm (Pneumatic Skin Flattening) Systems (K(071469), (K071943) & (K062589) 4. Description: The Serenity Pro PSF TM System is a device which has the ability to produce a… | 2006 |
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 16 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- None of the 53 ancestors has a recall.
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 Candela-Inolase Serenity Pro PSF TM (Pneumatic Skin Flattening) System is indicated for the following uses:
As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072925: Candela-Inolase Serenity Pro PSF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072925
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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