GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES— 510(k) K062719
Substantially EquivalentLaserscope
FDA 510(k) clearance K062719 for GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES, Substantially Equivalent on 2006-12-01. Applicant: Laserscope. Device class: 2.
Clearance details
- Applicant
- Laserscope
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GEX
view allMore clearances from Laserscope
view all- K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
- K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
- K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES
- K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
- K010834 — LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K062719
K-number listed on FDA's recall record- Z-1392-2022 — GreenLight HPSEA Laser Fibers, UPN 0010-2092
- Z-0700-2013 — GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062719.
Data sourced from openFDA. This site is unofficial and independent of the FDA.