510(k) · Cleared
ClearedStratapulse TS and Stratapulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Photonics · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Jun 17, 2009 as substantially equivalent to K082484 (Genesis Biosystems, Inc., 2008) after an 82-day review. Its family tree reaches back 10 generations to 1992. 3 later devices descend from it.
- Decided
- Jun 17, 2009
- Review
- 82 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910422 (1992). 89 ancestors in all, the oldest K885026 (1989). 3 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 backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 2 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 1 generation backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- This deviceK090837 Stratapulse TS and StratapulseAdvanced Medical Photonics · 2009
- Descendant · cites it directly · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK220794 10PLTentech Co., Ltd. · 2022
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 backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 2 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 1 generation backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- This deviceK090837 Stratapulse TS and StratapulseAdvanced Medical Photonics · 2009
Most influential descendants
Showing 3 of 3 · See allView 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 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| −2 | K053324 | Chromolite System | Chromogenex Plc | 2006 | — |
| −1 | K082484 | Accelawave System | Genesis Biosystems, Inc. | 2008 | — |
| 0 (this device) | K090837 | Stratapulse TS and Stratapulse | Advanced Medical Photonics | 2009 | — |
| +1 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +2 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
| +2 | K220794 | 10PL | Tentech Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K082484 | Accelawave SystemSummary page 1…Product Code: ONF Regulation Number: 21 CFR 878.4810 3. Legally-marketed Equivalent Devices Accelawave System: k082484 The StrataPulse IPL System (Model STRATAPULSE TS and Model STRATAPULSE) is substantially equivalent to other legally marketed fl… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102857 | Ahwon's Ipl System | 2011 | 2 |
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 17 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 89 ancestors have a recall of any class.
- Of its descendants, K102857 (Ahwon Medi Instrument Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K082484.
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. 2009, 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?
Indications For Use (For Fitzpatrick Skin Types See Indications and Filters vs. Skin Types Chart Below): The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions: · Permanent hair reduction- long-term stable reduction in number of hairs re-growing…
Read the full statement (249 words)
Indications For Use (For Fitzpatrick Skin Types See Indications and Filters vs. Skin Types Chart Below):
The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:
· Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.
· Treatment of:
o Moderate inflammatory acne vulgaris
o Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
o Cutaneous lesions including scars
o Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations.
* Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery procedures to:
o Reduce pain during light treatment (via partial anesthesia from cooling).
o Reduce discomfort during and/or associated with light treatment
o Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation.
o Allow the use of higher light or laser fluences for light treatments (such as for hair reduction and the treatment of vascular or pigmented lesions)
o Reduce potential side effects of light treatment (such as for hair reduction and the treatment of vascular or pigmented lesions)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090837: Stratapulse TS and Stratapulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090837
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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