LASERTX - DIODE LASER & DELIVERY SYSTEM— 510(k) K060326
Substantially EquivalentProsurg, Inc.
FDA 510(k) clearance K060326 for LASERTX - DIODE LASER & DELIVERY SYSTEM, Substantially Equivalent on 2006-04-05. Applicant: Prosurg, Inc.. Device class: 2.
Clearance details
- Applicant
- Prosurg, Inc.
- 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 Prosurg, Inc.
view all- K152511 — Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
- K152466 — Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
- K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
- K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.