NaturaLase CO2 Laser System— 510(k) K152529
Substantially EquivalentFocus Medical, LLC
FDA 510(k) clearance K152529 for NaturaLase CO2 Laser System, Substantially Equivalent on 2016-02-04. Applicant: Focus Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Focus Medical, LLC
- 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
- Abbreviated
- Location
- Bethel, CT, US
Recent devices under product code GEX
view allMore clearances from Focus Medical, LLC
view all- K152737 — Lite Touch
- K151473 — NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
- K110333 — NATURALASE CO2 LASER SYSTEM
- K101152 — NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
- K041829 — FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
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.