510(k) · Cleared
ClearedModel 1000 Holmium Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Star Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 20, 2000 as substantially equivalent to K992574 (Trimedyne, Inc., 1999) after a 31-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jan 20, 2000
- Review
- 31 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992574 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992574 Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium…Trimedyne, Inc. · 1999
- This deviceK994273 Model 1000 Holmium Laser SystemNew Star Lasers, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992574 | Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System… | Trimedyne, Inc. | 1999 | — |
| 0 (this device) | K994273 | Model 1000 Holmium Laser System | New Star Lasers, Inc. | 2000 | — |
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 |
|---|---|---|---|
| * | K992574 | Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models…Summary page 1…er System Surgical Laser System Instrument, Surgical, Powered Laser 21 CFR § 878.4810 Omni Pulse™ Holmium Laser System, Model 1210 Trimedyne, Inc. Irvine, California K992574 The New Star Model 1000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wav… | 1999 |
| † | K933007 | Slase 210 & Slase 210 Plus Holmium Laser Systems | 1994 |
| † | K942542 | Slase 210 Plus Holmium Laser System | 1994 |
| † | K945156 | Slase 210 Plus Holmium Laser System | 1995 |
| † | K912879 | Model Slase 210 Holmium (THC:Yag) Laser System | 1992 |
| † | K920248 | Model Slase 210 Holmium Laser System | 1992 |
| † | K921724 | Unnamed device |
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.
What does this lineage say?
- Its one ancestor has no 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 New Star Lasers, Inc. Model 100 Holmium Laser System is indicated for the following;: Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/Gastrointestinal Surgery, including: Cholecystectomy, lysis og adhesions, appendectomy, biopsy, pylrosternotomy (sp®), benign and malignant lestions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi…
Read the full statement (294 words)
The New Star Lasers, Inc. Model 100 Holmium Laser System is indicated for the following;:
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/Gastrointestinal Surgery, including:
Cholecystectomy, lysis og adhesions, appendectomy, biopsy, pylrosternotomy (sp®), benign and malignant lestions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
Incision, excision, resection, ablation, coabulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas.
General Surgery of soft tissues, including:
skin incision, tissue dissection, excision or external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation.
Genitourinary Surgery, including:
superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.
Gynecological Surgery during open and endoscopic procedures.
Lithotripsy and Percutaneous Urinary Lithotripsy, including:
fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including:
knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinecular release, and debridement of the degenerative knees.
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including:
endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.
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/K994273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994273: Model 1000 Holmium 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/K994273
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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