510(k) · Cleared
ClearedAurora SL
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 Nov 18, 1999 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 87 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
87 later devices descend from it, 2 citing it directly.
- This deviceK993285 Aurora SLPremier Laser Systems, Inc. · 1999
- Descendant · cites it directly · 86 of its ownK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- Descendant · 2 generations on · 71 of its ownK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- Descendant · 3 generations on · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- Descendant · cites it directly · 40 of its ownK062619 Denlaser 800 PlusCAO Group, Inc. · 2006
- Descendant · 4 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005 · cites it directly86descendants
- K062258Genesis Diode LaserIvoclar Vivadent, Inc. · 2007 · 2 generations on71descendants
- K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · 3 generations on50descendants
- K062619Denlaser 800 PlusCAO Group, Inc. · 2006 · cites it directly40descendants
- K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993285 | Aurora SL | Premier Laser Systems, Inc. | 1999 | — |
| +1 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| +2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| +3 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| +1 | K062619 | Denlaser 800 Plus | CAO Group, Inc. | 2006 | — |
| +4 | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 0 |
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? (87)
See all 872 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K050453 (Ivoclar Vivadent, Inc., 2005) has gone furthest, with 86 descendants of its own.
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 II
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
Liver 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
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues.
Examples:
Hemorrhoidectomy
Excision, vaporization and hemostasis 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/K993285 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993285: Aurora SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993285
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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