LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)— 510(k) K011960
Substantially EquivalentLares Research, Inc.
FDA 510(k) clearance K011960 for LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4), Substantially Equivalent on 2001-12-21. 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
view allMore clearances from Lares Research, Inc.
view all- K141221 — LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
- K031540 — APEX ELECTRIC HANDPIECE SYSTEM
- K983524 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
- 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.