510(k) · Cleared
ClearedEdge CO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jm System Co., Ltd. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Nov 10, 2010 as substantially equivalent to K081424 (Cynosure, Inc., 2009) after a 253-day review. Its family tree reaches back 1 generation to 2009. 10 later devices descend from it.
- Decided
- Nov 10, 2010
- Review
- 253 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081424 (2009). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK081424 Affirm CO2 and Affirm CO2 HPCynosure, Inc. · 2009
- This deviceK100590 Edge CO2 Laser SystemJm System Co., Ltd. · 2010
- Descendant · cites it directly · 7 of its ownK162169 EdgeOne CO2 LaserJeisys Medical, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK201109 CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 2 of its ownK221597 CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK241670 Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser…Beijing Adss Development Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK111831 MX-7000 MicroxelBio-Med USA, Inc. · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162169EdgeOne CO2 LaserJeisys Medical, Inc. · 2016 · cites it directly7descendants
- K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · 2 generations on5descendants
- K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. · 2022 · 3 generations on2descendants
- K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd. · 2024 · 4 generations on1descendant
- K111831MX-7000 MicroxelBio-Med USA, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081424 | Affirm CO2 and Affirm CO2 HP | Cynosure, Inc. | 2009 | — |
| 0 (this device) | K100590 | Edge CO2 Laser System | Jm System Co., Ltd. | 2010 | — |
| +1 | K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016 | — |
| +2 | K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +3 | K221597 | CO2 Laser System | Smedtrum Medical Technology Co., Ltd. | 2022 | — |
| +4 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy… | Beijing Adss Development Co., Ltd. | 2024 | — |
| +1 | K111831 | MX-7000 Microxel | Bio-Med USA, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K081424 | Affirm CO2 and Affirm CO2 HPSummary page 1…laser 79-ONG, 21 CFR 878-481 0 Legally Marketed Predicate Cynosure Affirm 002 Laser Device: K081424 Description of the Edge 002 The Edge 002 laser has a wavelength of 10,600nm. CO2 fractional laser… | 2009 |
What descends from it? (10)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The Edge CO2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.
The Edge CO2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100590 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100590: Edge CO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100590
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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