510(k) · Cleared
ClearedCynosure Cellulaze Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · OYW Laser, Cellulite Appearance
Cleared on Jan 26, 2012 as substantially equivalent to K091537 (Cynosure, Inc., 2009) after a 510-day review. Its family tree reaches back 1 generation to 2009. 39 later devices descend from it.
- Decided
- Jan 26, 2012
- Review
- 510 days
- Class
- Class II
- Product code
- OYW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091537 (2009). 39 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK091537 Cynosure Smartlipo Multiwavelength Laser with 1440NM WavelengthCynosure, Inc. · 2009
- This deviceK102541 Cynosure Cellulaze LaserCynosure, Inc. · 2012
- Descendant · cites it directly · 25 of its ownK121127 Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM…Cynosure, Inc. · 2012
- Descendant · 2 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · 3 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- Descendant · cites it directly · 12 of its ownK201801 Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
- Descendant · 2 generations on · 7 of its ownK223237 SofWave SystemSofwave Medical, Ltd. · 2022
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K121127Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersCynosure, Inc. · 2012 · cites it directly25descendants
- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 2 generations on23descendants
- K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 3 generations on13descendants
- K201801Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021 · cites it directly12descendants
- K223237SofWave SystemSofwave Medical, Ltd. · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091537 | Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength | Cynosure, Inc. | 2009 | — |
| 0 (this device) | K102541 | Cynosure Cellulaze Laser | Cynosure, Inc. | 2012 | — |
| +1 | K121127 | Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers | Cynosure, Inc. | 2012 | — |
| +2 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| +3 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
| +1 | K201801 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2021 | — |
| +2 | K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 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 OYW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091537 | Cynosure Smartlipo Multiwavelength Laser with 1440NM WavelengthSummary page 1…ical Laser System Laser surgical instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810 SmartLipo Multiwavelength with 1440nm Wavelength, K091537 The Cynosure Cellulaze laser is an Nd:YAG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is house… | 2009 |
What descends from it? (39)
See all 392 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OYW devicesOYW Laser, Cellulite Appearance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OYW
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OYW
Too few OYW 510(k)s in any year since 2007 to give a median.
Recalls per year · OYW
No recall names OYW since 2007.
Adverse event reports per year · OYW
2in 2019
MAUDE reports naming product code OYW, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cynosure Cellulaze Laser is intended for the short term improvement in
the appearance of cellulite.
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/K102541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102541: Cynosure Cellulaze Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102541
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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