510(k) · Cleared
ClearedProtege II ER: Yag Laser System and Accessoies (Upgrade)
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 31, 1998 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 31, 1998
- Review
- 85 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
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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 Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dentistry: Soft tissue (incision, excision, ablation and coagulation) Dermatology/Plastic Surgery: Indications include epidermal…
Read the full statement (247 words)
The Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dentistry: Soft tissue (incision, excision, ablation and coagulation)
Dermatology/Plastic Surgery: Indications include epidermal nevi, telangiectasia, spider veins, actinic keratosis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.
General Surgery: Indications include surgical incision/excision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Oral/Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectomy.
Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
Arthroscopy, including open and laparoscopic procedures
Orthopedic Surgery
Thoracic 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/K981627 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981627: Protege II ER: Yag Laser System and Accessoies (Upgrade).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981627
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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