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iPulse Model I150

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083748

by Cyden Limited

Identifiers

510(k) Number
K083748 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 iPulse Model I150 is an intense pulsed light (IPL) device classified as a laser surgical instrument. It emits adjustable wavelengths between 530nm and 1200nm to target and reduce hair follicles, making it suitable for long-term or permanent hair reduction procedures in general, plastic surgery, and dermatology settings.

This device is intended for use by trained professionals in clinical environments and is supplied as a reusable medical instrument. The iPulse Model I150 holds FDA 510(k) clearance under Special Review (K083748) for its intended applications. No specific sterility or MRI safety information is provided in the available data.

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: IPULSE, MODEL: I150 by CYDEN LIMITED | FDA 510 (k) Summary, IPULSE, MODEL: I150 (K083748) — FDA 510 (k) | Innolitics, Ipulse, Model: I150 510 (k) FDA Premarket Notification K083748 CYDEN ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cyden Limited

Sources (1)

  • FDA 510(k) K083748 24 fields · synced Sep 19, 2026