510(k) · Cleared
ClearedSR-1 Skin Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AVAVA, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Nov 21, 2022 as substantially equivalent to K202884 (AVAVA, Inc., 2021) after a 203-day review. Its family tree reaches back 22 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 21, 2022
- Review
- 203 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K910422 (1992). 328 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 22 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 18 generations between
- 3 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 2 generations backK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- 1 generation backK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
- This deviceK221268 SR-1 Skin Treatment SystemAVAVA, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK223871 Miria Skin Treatment SystemAVAVA, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK250402 AVAVA™ Skin Treatment SystemAVAVA, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK252155 AVAVA™ Skin Treatment SystemAVAVA, Inc. · 2025
Show all 22 generations
- Root · 22 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 21 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 20 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 19 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 18 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 17 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 16 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 15 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 14 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 13 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 12 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 11 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 10 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 9 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 8 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 7 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 6 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 5 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 4 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 3 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 2 generations backK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- 1 generation backK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
- This deviceK221268 SR-1 Skin Treatment SystemAVAVA, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −21 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −20 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −19 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −18 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −17 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −16 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −15 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −14 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −13 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −12 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −11 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −10 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −9 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −8 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −7 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −6 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −5 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −4 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| −3 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| −2 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| −1 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
| 0 (this device) | K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022 | — |
| +1 | K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023 | — |
| +2 | K250402 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025 | — |
| +3 | K252155 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 24 | 0 |
| 1998 | 19 | 0 |
| 1999 | 13 | 0 |
| 2000 | 26 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 30 | 0 |
| 2004 | 17 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K202884 | SR-1 Skin Treatment SystemSummary page 4…with Focal Point Technology Date Summary Prepared: October 28, 2022 Primary Predicate Device(s) SR‐1 Skin Treatment System: K202884 Device Description The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted sp… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223871 | Miria Skin Treatment System | 2023 | 2 |
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 10 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 328 ancestors have a recall of any class.
- Of its descendants, K223871 (AVAVA, Inc., 2023) has gone furthest, with 2 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. 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?
The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221268 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221268: SR-1 Skin Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221268
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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