510(k) · Cleared
ClearedNoable Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daeju Meditech Engineering Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Mar 7, 2025 as substantially equivalent to K173676 (Hironic Co., Ltd., 2018) after a 221-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Mar 7, 2025
- Review
- 221 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002421 (2000). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
- 5 generations backK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
- 4 generations backK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- 3 generations backK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- 2 generations backK041242 Candela Smoothbeam Laser SystemCandela Corp. · 2004
- 1 generation backK173676 A-FITHironic Co., Ltd. · 2018
- This deviceK242207 Noable LaserDaeju Meditech Engineering Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002421 | Candela Mid IR Diode Laser System | Candela Corp. | 2000 | — |
| −5 | K013825 | Candela Smoothbeam Laser System | Candela Corp. | 2002 | 1 |
| −4 | K022884 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| −3 | K030834 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| −2 | K041242 | Candela Smoothbeam Laser System | Candela Corp. | 2004 | — |
| −1 | K173676 | A-FIT | Hironic Co., Ltd. | 2018 | — |
| 0 (this device) | K242207 | Noable Laser | Daeju Meditech Engineering Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 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 |
|---|---|---|---|
| * | K173676 | A-FITSummary page 5…de: GEX • Panel: General & Plastic Surgery • Regulation Number: 21 CFR §878.4810 • Device Class: Class II • Date prepared: 03/06/2025 Predicate Device Primary Predicate K173676, A-fit manufactured by Hironic Co., Ltd. Reference K041242, CANDELA SMOOTHBEAM LASER SYSTEM manufactured by CANDELA CORP. Indica… | 2018 |
| † | K041242 | Candela Smoothbeam Laser System | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,
Treatment of back acne
Treatment of atrophic acne scars
Treatment of facial wrinkles
Treatment of mild to moderate acne vulgaris
Treatment of Sebaceous Hyperplasia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242207: Noable Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242207
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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