510(k) · Cleared
ClearedPolaris Diode Laser System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xintec Corporation · GEX Powered Laser Surgical Instrument
Cleared on Jul 30, 1999 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 30, 1999
- Review
- 134 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dermatology and Plastic Surgery for…
Read the full statement (132 words)
The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications.
Specific surgical specialties include:
Dermatology and Plastic Surgery for
Photocoagulation of dermatological vascular lesions, including port wine stains,
telangiectasia, angioma, spider nevi, and other benign vascular lesions.
Photothermolysis of blood vessels (treatment of facial and leg veins)
Removal of pigmented lesions
Photothermolysis
Dentistry (soft tissue only), including sulcular debridement (removal of diseased or
inflamed soft tissue in the periodontal pocket) and oral surgery;
Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only);
Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery;
Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990914: Polaris Diode Laser System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990914
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026