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Profile 1320 Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022381

by Sciton, Inc

Identifiers

510(k) Number
K022381 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Profile 1320 Laser System is an Nd:YAG laser emitting at 1320 nm, consisting of a laser console, internal computer, control panel/display, optical delivery system, and footswitch. It is used for incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissue. The device is intended for use in general surgery and dermatology.

The Profile 1320 Laser System is supplied with a laser console, articulated arm with handpiece or scanner, and footswitch. It has received FDA 510(k) authorization, with the reference number K022381. The device is designed for use in a clinical setting, with a user manual available for operation and maintenance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PROFILE 1320 LASER SYSTEM (K032459) — FDA 510(k) | Innolitics, PROFILE 1320 LASER SYSTEM by SCITON, INC. | FDA 510 (k) Summary, PROFILE 1320 LASER SYSTEM (K022381) — FDA 510(k) | Innolitics, Sciton Profile 1320 User Manual - PDF Download - Rock Bottom Lasers

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sciton, Inc

Sources (1)

  • FDA 510(k) K022381 24 fields · synced Sep 21, 2026