510(k) · Cleared
ClearedMultifrax Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Medical Corporation · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Jun 3, 2022 as substantially equivalent to K130193 (Solta Medical, Inc., 2013) after a 240-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Jun 3, 2022
- Review
- 240 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K910422 (1992). 132 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK063808 Fraxel IV SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- This deviceK213332 Multifrax Laser SystemParadigm Medical Corporation · 2022
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 4 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK063808 Fraxel IV SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- This deviceK213332 Multifrax Laser SystemParadigm Medical Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −4 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −3 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −2 | K063808 | Fraxel IV SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −1 | K130193 | Fraxel Dual 1550/1927 Laser System | Solta Medical, Inc. | 2013 | — |
| 0 (this device) | K213332 | Multifrax Laser System | Paradigm Medical Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K130193 | Fraxel Dual 1550/1927 Laser SystemSummary page 4…l and plastic surgery and dermatology; 21 C.F.R. §878.4810 Class II Product Code: ONG Predicate Device Solta Medical, Inc. Fraxel Dual 1550/1927 Laser System cleared in K130193 Device Description The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengt… | 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 30 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 132 ancestors have a recall of any class.
- 10 other devices also cite its predicate K130193.
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. 2022, 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?
1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Multifrax 1927 nm…
Read the full statement (110 words)
1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Multifrax 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213332: Multifrax Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213332
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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