510(k) · Cleared
ClearedShaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shaser, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 13, 2015 as substantially equivalent to K141583 (Shaser, Inc., 2014) after a 128-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Feb 13, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K950019 (1995). 48 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 17 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 13 generations between
- 3 generations backK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- 2 generations backK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
- 1 generation backK141583 Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc. · 2014
- This deviceK142924 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc. · 2015
Show all 17 generations
- Root · 17 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 16 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 15 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 14 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 13 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 12 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 11 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 10 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 9 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 8 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 7 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 6 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 5 generations backK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- 4 generations backK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
- 3 generations backK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- 2 generations backK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
- 1 generation backK141583 Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc. · 2014
- This deviceK142924 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −16 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −15 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −14 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −13 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −12 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −11 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −10 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −9 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −8 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −7 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −6 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −5 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| −4 | K132266 | Shaser HRS2 RX Hair Removal System | Shaser, Inc. | 2013 | — |
| −3 | K133201 | Shaser V-Mini 2 Hair Removal System | Shaser, Inc. | 2014 | — |
| −2 | K140631 | Lumena FH Hair Removal System | Shaser, Inc. | 2014 | — |
| −1 | K141583 | Shaser Skin Beauty Intense Pulsed Light System Family | Shaser, Inc. | 2014 | — |
| 0 (this device) | K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family | Shaser, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| Kept off the family tree | K070833 | FDA’s K070833 is Atlantis Abutment for Astra Implant Our reading of the summary gave K070833, FDA’s number for Atlantis Abutment for Astra Implant (Atlantis Components, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sciton Profile Multi-Platform System”. Kept off the family tree. Summary page 4…l Instrument with Thermal Effect 79-ONF, 21 CFR 878.4810 Equivalent Devices: Sciton Profile Multi-Platform System (K070833) Shaser Skin Beauty Intense Pulsed Light System Family (K141583) Device Description: Shaser Skin Be… | 2007 |
| * | K141583 | Shaser Skin Beauty Intense Pulsed Light System FamilySummary page 4…, 21 CFR 878.4810 Equivalent Devices: Sciton Profile Multi-Platform System (K070833) Shaser Skin Beauty Intense Pulsed Light System Family (K141583) Device Description: Shaser Skin Beauty SkinREJUVTM Intense Pulsed Light System Family devices are… | 2014 |
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 20 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 48 ancestors has a recall of any class.
- 1 other device also cites its predicate K141583.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to
provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosecea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and
venous malformations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142924: Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142924
Report an extraction error
Are you the manufacturer?
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