FDA 510(k) · Laser Associated Sciences
K182494: FlowMet-R (Laser Associated Sciences, Inc.)
Laser Associated Sciences, Inc. received FDA 510(k) K182494 for FlowMet-R, with a decision date of Feb 27, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K182494 |
|---|---|
| Pathway | 510(k) |
| Applicant | Laser Associated Sciences, Inc. |
| Device name | FlowMet-R |
| Product code | DPW: Flowmeter, Blood, Cardiovascular |
| Regulation (21 CFR) | 870.2100 |
| Device class | Class 2 |
| Date received | Sep 11, 2018 |
| Decision date | Feb 27, 2019 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The FlowMet-R is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.