510(k) · Cleared
ClearedShaser Skin Beauty Intense Pulsed Light System Family for Acne
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shaser, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on May 27, 2015 as substantially equivalent to K141583 (Shaser, Inc., 2014) and 1 other predicate after a 111-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- May 27, 2015
- Review
- 111 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K950019 (1995). 134 ancestors in all, the oldest K800617 (1980). 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 deviceK150282 Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, 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 deviceK150282 Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, 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) | K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | Shaser, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 14 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141583 | Shaser Skin Beauty Intense Pulsed Light System FamilySummary page 4…Effect 79-ONF, 21 CFR 878.4810 Equivalent Devices: Shaser Skin Beauty Intense Pulsed Light System Family (K141583) CLRS Technology Corp. CLARO (K090744) Device Description: Shaser Skin Beauty Intense… | 2014 |
| * | K090744 | CLAROSummary page 4…CFR 878.4810 Equivalent Devices: Shaser Skin Beauty Intense Pulsed Light System Family (K141583) CLRS Technology Corp. CLARO (K090744) Device Description: Shaser Skin Beauty Intense Pulsed Light System Family For Acne is… | 2010 |
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.
- 5 of the 134 ancestors have a recall of any class.
- 1 other device also cites its predicate K141583.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150282: Shaser Skin Beauty Intense Pulsed Light System Family for Acne.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150282
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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