LASESONICS LOW POWER CO2 LASER SYSTEM— 510(k) K953917
Substantially EquivalentHeraeus Surgical, Inc.
FDA 510(k) clearance K953917 for LASESONICS LOW POWER CO2 LASER SYSTEM, Substantially Equivalent on 1995-10-26. Applicant: Heraeus Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Surgical, 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
- Milpitas, CA, US
Recent devices under product code GEX
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- K951215 — LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER
- K943716 — LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES
- K944346 — LASERSONICS RADIANCE DIODE LASER SYSTEMS AND 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.