Collagentex Rx-1— 510(k) K162022

Substantially Equivalent

Tanses Technologies, Inc.

FDA 510(k) clearance K162022 for Collagentex Rx-1, Substantially Equivalent on 2016-12-22. Applicant: Tanses Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Tanses Technologies, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2016-07-21
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHN

K254024 — MR5 Activ Pro2026-05-19
K251903 — Erchonia DPN Laser (Model# EVRL)2026-02-19
K252273 — Therapy US2025-12-12
K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)2025-01-24
K232813 — Therapy EC, Therapy XT2024-12-19

More clearances from Tanses Technologies, Inc.

K180585 — Collagentex Rx-62018-05-11
K152412 — T-32; T-40; T-44; T-52; T-72; TT-502016-04-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.