510(k) · Cleared
ClearedAurora HL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Laser Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 22, 1999 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 22, 1999
- Review
- 69 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?
EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: Removal of benign lesions from the ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in-situ Ablation and vaporization of hyperkeratosis Excision of carcinoma of the larynx Laryngeal…
Read the full statement (375 words)
EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples:
Removal of benign lesions from the ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in-situ
Ablation and vaporization of hyperkeratosis
Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of Herpes Simplex I and IX
Pulpotomy and pulpotomy as an adjunct to root canal therapy
Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples:
Meniscectomy
Synovectomy
Chondromalacia
GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples:
Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcinoma
Excision of polyps
GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. Examples:
Matrixectomy
Excision of neuromas
Excision of periungual & subungual warts
Port wine stain removal
Excision of plantar warts
Excision of keloids
Cholecystectomy
Bowel resection
Excision of cutaneous lesions
Hemorrhoidectomy
Appendectomy
Debridement of decubitus ulcer
Hepatobiliary
Mastectomy
Dermabrasion
Vaporization & hemostasis of capillary hemangioma
Excision, vaporization & hemostasis of abdominal tumors
Excision, vaporization & hemostasis or rectal pathology
Pilondial cystectomy
Herniorrhaphy
Adhesiolysis
Parathyroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
GY/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:
Hemorrhondectomy
Excision, vaporization and hemostasns of rectal pathology
Excision, vaporization, and hemostasis of abdominal tumors
GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. Examples:
Endometrial ablation
Excision or vaporization of condylomata acuminata
Vaporization of CIN (cervical intraepithelelial neoplasis)
Cervical conization
Menorrhagia
NEUROSURGERY:
Hemostasis
Hemostasis for myangioma
OPHTHALMOLOGY:
Incision, excision and vaporization of tissue surrounding the eye and orbit
Photocoagulation of the retina
PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. Examples:
Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction
UROLOGY: Hemostasis, vaporization and excision of tissues. Examples:
Vaporization of urethral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia
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/K992374 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992374: Aurora HL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992374
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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