Looper (Model: ZX-579S)— 510(k) K202055
Substantially EquivalentHeat IN A Click, LLC
FDA 510(k) clearance K202055 for Looper (Model: ZX-579S), Substantially Equivalent on 2021-04-16. Applicant: Heat IN A Click, LLC. Device class: 2.
Clearance details
- Applicant
- Heat IN A Click, LLC
- Product code
- Code OLP
- 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
- Homestead, FL, US
Recent devices under product code OLP
view allMore clearances from Heat IN A Click, LLC
view allAdverse events under product code OLP
product code OLP- Other
- 1
- Total
- 1
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.