LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)— 510(k) K983524
Substantially EquivalentLares Research, Inc.
FDA 510(k) clearance K983524 for LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP), Substantially Equivalent on 1999-04-01. Applicant: Lares Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Lares Research, 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
- Chico, CA, US
Recent devices under product code GEX
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- K011960 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
- K961163 — LARES RESEARCH AS-1 LOWSPEED HANDPIECE
- K905542 — LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
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.