NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)— 510(k) K925130
Substantially EquivalentLaserscope
FDA 510(k) clearance K925130 for NESSY SURESTICK(TM)/STANDARD SURESTICK(TM), Substantially Equivalent on 1993-03-18. Applicant: Laserscope. Device class: 2.
Clearance details
- Applicant
- Laserscope
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- 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 GEI
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- K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
- K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES
- K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.