510(k) · Cleared
ClearedCAPRI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ORO Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 26, 2026 as substantially equivalent to K041242 (Candela Corp., 2004) after a 58-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Feb 26, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002421 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK254271 CAPRIORO Co., Ltd. · 2026
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) | K254271 | CAPRI | ORO Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K041242 | Candela Smoothbeam Laser SystemSummary page 5…surgical instrument for use in general and plastic surgery and in dermatology Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX III. PREDICATE DEVICE K041242, Candela Smoothbeam Laser System, GEX No reference devices were used in this submission. IV. DEVICE DESCRIPTION CAPRI is a diod… | 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 26 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 6 ancestors have a recall of any class.
- 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. 2026, 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?
CAPRI is indicated 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/K254271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254271: CAPRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254271
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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