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 Apr 13, 2021 as substantially equivalent to K130193 (Solta Medical, Inc., 2013) and 3 other predicates after a 197-day review. Its family tree reaches back 21 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 13, 2021
- Review
- 197 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K910422 (1992). 327 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 21 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 17 generations between
- 3 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 2 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 1 generation backK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- This deviceK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK221268 SR-1 Skin Treatment SystemAVAVA, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK223871 Miria Skin Treatment SystemAVAVA, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK250402 AVAVA™ Skin Treatment SystemAVAVA, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK252155 AVAVA™ Skin Treatment SystemAVAVA, Inc. · 2025
Show all 21 generations
- Root · 21 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 20 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 19 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 18 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 17 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 16 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 15 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 14 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 13 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 12 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 11 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 10 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 9 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 8 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 7 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 6 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 5 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 4 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 3 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 2 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 1 generation backK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- This deviceK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K221268SR-1 Skin Treatment SystemAVAVA, Inc. · 2022 · cites it directly3descendants
- K223871Miria Skin Treatment SystemAVAVA, Inc. · 2023 · 2 generations on2descendants
- K250402AVAVA™ Skin Treatment SystemAVAVA, Inc. · 2025 · 3 generations on1descendant
- K252155AVAVA™ Skin Treatment SystemAVAVA, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −20 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −19 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −18 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −17 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −16 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −15 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −14 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −13 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −12 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −11 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −10 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −9 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −8 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −7 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −6 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −5 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −4 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −3 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| −2 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| −1 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| 0 (this device) | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
| +1 | K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022 | — |
| +2 | K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023 | — |
| +3 | K250402 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025 | — |
| +4 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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? (4)
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…Microbeam/Fractional Output Date Summary Prepared: September 25, 2020 Name of Predicate Device(s) * Fraxelo DUAL 1550/1927: K130193, K060310 * Lumenis® Stellar M22 m : K193500, K130028 Intended Use The SR-1 Skin Treatment System is indicated for use i… | 2013 |
| * | K060310 | Fraxel II SR Laser System and AccessoriesSummary page 4…Microbeam/Fractional Output Date Summary Prepared: September 25, 2020 Name of Predicate Device(s) * Fraxelo DUAL 1550/1927: K130193, K060310 * Lumenis® Stellar M22 m : K193500, K130028 Intended Use The SR-1 Skin Treatment System is indicated for use in dermato… | 2006 |
| * | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemSummary page 4…Date Summary Prepared: September 25, 2020 Name of Predicate Device(s) * Fraxelo DUAL 1550/1927: K130193, K060310 * Lumenis® Stellar M22 m : K193500, K130028 Intended Use The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagula… | 2020 |
| * | K130028 | Resurfx 1565NM Laser ModuleSummary page 4…Summary Prepared: September 25, 2020 Name of Predicate Device(s) * Fraxelo DUAL 1550/1927: K130193, K060310 * Lumenis® Stellar M22 m : K193500, K130028 Intended Use The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of s… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221268 | SR-1 Skin Treatment System | 2022 | 3 |
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 29 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 327 ancestors have a recall of any class.
- Of its descendants, K221268 (AVAVA, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 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. 2021, 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 SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The SR-I 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 SR-1 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/K202884 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202884: 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/K202884
Report an extraction error
Are you the manufacturer?
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