ReBorn (1050nm)— 510(k) K233962

Substantially Equivalent

Lightfective , Ltd.

FDA 510(k) clearance K233962 for ReBorn (1050nm), Substantially Equivalent on 2024-04-16. Applicant: Lightfective , Ltd.. Device class: 2.

Clearance details

Applicant: Lightfective , Ltd.
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2023-12-15
Decision date: 2024-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKT

K240658 — 1060nm laser body slimming machine2024-05-13
K231971 — DEKA PHYSIQ 3602023-09-26
K231131 — Diode Laser Body Sculpture Systems2023-06-22
K222226 — EON2023-02-17
K222265 — Diosculpt2022-09-23

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