510(k) · Cleared
Recalled · Class II · 2014Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermage, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Sep 8, 2010 as substantially equivalent to K060310 (Reliant Technologies, Inc., 2006) and 1 other predicate after a 99-day review. Its family tree reaches back 10 generations to 1992. 28 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 8, 2010
- Review
- 99 days
- Class
- Class II
- Product code
- ONG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910422 (1992). 128 ancestors in all, the oldest K820106 (1982). 28 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 1 generation backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- This deviceK101490 Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc. · 2010
- Descendant · cites it directly · 25 of its ownK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK171009 LASEMD Laser SystemLutronic Corporation · 2017
- Descendant · 2 generations on · 5 of its ownK182173 Joule SystemSciton, Inc · 2019
- Descendant · 3 generations on · 4 of its ownK223727 LavieenWontech Co., Ltd. · 2023
- Descendant · 2 generations on · 4 of its ownK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
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 backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 1 generation backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- This deviceK101490 Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc. · 2010
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013 · cites it directly25descendants
- K171009LASEMD Laser SystemLutronic Corporation · 2017 · 2 generations on8descendants
- K182173Joule SystemSciton, Inc · 2019 · 2 generations on5descendants
- K223727LavieenWontech Co., Ltd. · 2023 · 3 generations on4descendants
- K202884SR-1 Skin Treatment SystemAVAVA, Inc. · 2021 · 2 generations on4descendants
View 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 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −1 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| 0 (this device) | K101490 | Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US | Thermage, Inc. | 2010 | — |
| +1 | K130193 | Fraxel Dual 1550/1927 Laser System | Solta Medical, Inc. | 2013 | — |
| +2 | K171009 | LASEMD Laser System | Lutronic Corporation | 2017 | — |
| +2 | K182173 | Joule System | Sciton, Inc | 2019 | — |
| +3 | K223727 | Lavieen | Wontech Co., Ltd. | 2023 | — |
| +2 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 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 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? (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 |
|---|---|---|---|
| * | K060310 | Fraxel II SR Laser System and Accessories | 2006 |
| * | K091420 | Fraxel RE: Store Laser System, Model SR1500Summary page 1…S Name: Fraxel re:store Laser System and Accessories 5 10(k) #: K06031I0 Name: Fraxel re:store® Dual Laser System and Accessories 5 10(k) #:K091420 DEVICE DESCRIPTION The Fraxel re~store® Dual Laser System consists of a 1550 nm. laser source and a 1927 rnm las… | 2009 |
What descends from it? (28)
See all 282 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2014 | Class II | Z-1463-2014 | Labeling Change Control | Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma. |
| Dec 15, 2010 | Not classified | Z-1010-2011 | Software design | The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 128 ancestors have a recall of any class.
- Of its descendants, K130193 (Solta Medical, Inc., 2013) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K060310.
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. 2010, 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 Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the 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 Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101490: Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101490
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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