510(k) · Cleared
ClearedMOSAIC 3D (Surgical Laser)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Aesthetic · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Jan 2, 2024 as substantially equivalent to K080932 (Lutronic Corporation, 2008) after a 60-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Jan 2, 2024
- Review
- 60 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910422 (1992). 147 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK080932 Mosaic Laser SystemLutronic Corporation · 2008
- This deviceK233550 MOSAIC 3D (Surgical Laser)Lutronic Aesthetic · 2024
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK080932 Mosaic Laser SystemLutronic Corporation · 2008
- This deviceK233550 MOSAIC 3D (Surgical Laser)Lutronic Aesthetic · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −3 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −1 | K080932 | Mosaic Laser System | Lutronic Corporation | 2008 | — |
| 0 (this device) | K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 11 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 ONG? 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 ONG device
- #1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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? (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 |
|---|---|---|---|
| * | K080932 | Mosaic Laser SystemSummary page 5…ONG (primary), GEX (secondary) 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed Lutronic Corporation K080932 (06/09/2008) Predicate Solta Medical, Inc K130193 (06/14/2013) Reference 807.92(a)(4) - Device d… | 2008 |
| † | K130193 | Fraxel Dual 1550/1927 Laser System | 2013 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 147 ancestors have a recall of any class.
- 1 other device also cites its predicate K080932.
How does its category compare?
All ONG devicesONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · ONG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONG
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONG
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONG
1in 2025
MAUDE reports naming product code ONG, 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 | 4 | 160 | 0 | 0 |
| 2010 | 4 | 176 | 1 | 3 |
| 2011 | 6 | 122 | 0 | 2 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 3 | 243 | 0 | 4 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 40 |
| 2018 | 2 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 3 | 203 | 0 | 2 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 2 | 11 |
| 2025 | 4 | 97 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233550: MOSAIC 3D (Surgical Laser).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233550
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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