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DP4 Microneedling device

by Equipmed USA, LLC 510(k)

Active United States

510(k) K221070

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221070 Date20 Dec 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QAI
Device Class
Class II
Regulation
21 CFR Part 878.4430
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent