510(k) · Cleared
ClearedA-FIT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hironic Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 14, 2018 as substantially equivalent to K041242 (Candela Corp., 2004) and 1 other predicate after a 288-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Sep 14, 2018
- Review
- 288 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002421 (2000). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
- 4 generations backK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
- 3 generations backK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- 2 generations backK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- 1 generation backK041242 Candela Smoothbeam Laser SystemCandela Corp. · 2004
- This deviceK173676 A-FITHironic Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK242207 Noable LaserDaeju Meditech Engineering Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242207Noable LaserDaeju Meditech Engineering Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002421 | Candela Mid IR Diode Laser System | Candela Corp. | 2000 | — |
| −4 | K013825 | Candela Smoothbeam Laser System | Candela Corp. | 2002 | 1 |
| −3 | K022884 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| −2 | K030834 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| −1 | K041242 | Candela Smoothbeam Laser System | Candela Corp. | 2004 | — |
| 0 (this device) | K173676 | A-FIT | Hironic Co., Ltd. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K041242 | Candela Smoothbeam Laser SystemSummary page 5…1 A-FIT 510(k) Summary 1) Predicate device for Laser – K041242 Predicate Device Proposed Device 510(K) Number K041242… | 2004 |
| * | K133739 | TrusculptSummary page 6…x 350 x 500 x 857 mm 508 mm) Operation time 10 minutes 10 minutes 2) Predicate device for RF – K133739 Predicate Device Proposed Device 510(K) Number K133739… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242207 | Noable Laser | 2025 | 0 |
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 18 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K242207 (Daeju Meditech Engineering Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K041242.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173676: A-FIT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173676
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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