510(k) · Cleared
ClearedPrima KTP Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 5, 1998 after a 90-day review. The FDA summary names its predicate without a number. 76 later devices descend from it.
- Decided
- Jan 5, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
76 later devices descend from it, 1 citing it directly.
- This deviceK973828 Prima KTP Laser SystemNidek, Inc. · 1998
- Descendant · cites it directly · 75 of its ownK041930 Varilite Laser SystemIridex Corporation · 2004
- Descendant · 2 generations on · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
- Descendant · 3 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- Descendant · 4 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- Descendant · 5 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K041930Varilite Laser SystemIridex Corporation · 2004 · cites it directly75descendants
- K091534Lightlas Model 532Lightmed Corp. · 2009 · 2 generations on72descendants
- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 3 generations on68descendants
- K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 4 generations on46descendants
- K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973828 | Prima KTP Laser System | Nidek, Inc. | 1998 | — |
| +1 | K041930 | Varilite Laser System | Iridex Corporation | 2004 | — |
| +2 | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| +3 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| +4 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| +5 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | Laserscope’s Aura KTP laser system Named without a submission number |
What descends from it? (76)
See all 761 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041930 | Varilite Laser System | 2004 | 75 |
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, K041930 (Iridex Corporation, 2004) has gone furthest, with 75 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?
The Prima KTP lasers are intended for the surgical treatment (i.e., incision, excision, abfation, coagulation, vaporization, debulking or hemostasis) of soft tissue in all surgical applications. This includes: Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery and Urology. Dermatology: Photocoagulation of cutaneous lesions, including the following general categories of lesions: Vascular lesions; Angiomas, hemangiomas, telangiectasia.…
Read the full statement (210 words)
The Prima KTP lasers are intended for the surgical treatment (i.e., incision, excision, abfation, coagulation, vaporization, debulking or hemostasis) of soft tissue in all surgical applications. This includes:
Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery and Urology.
Dermatology: Photocoagulation of cutaneous lesions, including the following general categories of lesions: Vascular lesions; Angiomas, hemangiomas, telangiectasia. Benign pigmented lesions; Nevi, Lentigines, chloasma, café-au-lait, Tattoos. Other Cutaneous Lesions, Verrucae, Skin Tags, Keratoses, Plaques. Cutaneous Lesion Treatment Goals Include; Hemostasis, Color Lightening, Blanching, Flattening, Reduction of Lesion Size.
Gastroenterology: Ablation of esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma. Ablation and excision of obstructive colorectal carcinoma. Hemorrhoidectomy. Ablation of villous adenoma in non-operative patients. Ablation of familial polyposis of the colon. Excision of gastric cancer. Ablation of sessile polyps of the colon.
Gynecology: Vaporizing, incising or coagulating tissue associated with treatments for conditions such as; Endometriosis, Cervical, vulvar and vaginal intraepithael neoplasia. Condyloma acuminata. Interuterine septum. Intrauterine adhesions. Submucosal fibroids.
Neurosurgery: Vaporizing, coagulating, incising, excising, debulking, and ablating neurological tissue in both open and endoscopic intracranial procedures such as: Third ventriculostomy, transseptal fenestration, intraventricular cysts fenestration, ventriculocystostomy, tumor biopsy and excision, removal of proximal shunts occluded by choriod plexus.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
Spinal Surgery: Percutaneous lumbar diskectomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973828: Prima KTP Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973828
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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