510(k) · Cleared
Recalled · 2010Fraxel RE: Store Laser System, Model SR1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solta Medical, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Oct 14, 2009 after a 154-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 62 later devices descend from it. It has been recalled once.
- Decided
- Oct 14, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- ONG
- Recalls
- 1
- Predicates
- 0
62 later devices descend from it, 3 citing it directly.
- This deviceK091420 Fraxel RE: Store Laser System, Model SR1500Solta Medical, Inc. · 2009
- Descendant · cites it directly · 41 of its ownK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- Descendant · 2 generations on · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- Descendant · cites it directly · 28 of its ownK101490 Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 25 of its ownK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- Descendant · 2 generations on · 24 of its ownK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K130028Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013 · cites it directly41descendants
- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · 2 generations on38descendants
- K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc. · 2010 · cites it directly28descendants
- K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013 · 2 generations on25descendants
- K170060M22 and ResurFx SystemsLumenis, Ltd. · 2017 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091420 | Fraxel RE: Store Laser System, Model SR1500 | Solta Medical, Inc. | 2009 | — |
| +1 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| +2 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +1 | K101490 | Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US | Thermage, Inc. | 2010 | 2 |
| +2 | K130193 | Fraxel Dual 1550/1927 Laser System | Solta Medical, Inc. | 2013 | — |
| +2 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (62)
See all 623 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 |
|---|---|---|---|---|
| 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?
- Of its descendants, K130028 (Lumenis, Ltd., 2013) has gone furthest, with 41 descendants of its own.
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. 2009, 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 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.
1925 nm: The Fraxel re:store 1925 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091420: Fraxel RE: Store Laser System, Model SR1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091420
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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