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Iriderm, Model Apex 800

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992298

by Iridex Corp

Identifiers

510(k) Number
K992298 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 Iriderm, Model Apex 800 is a laser device classified under the General & Plastic Surgery category (Product Code: GEX). It is a laser hair removal system designed to target and reduce hair growth through controlled laser energy delivery, targeting pigmented hair follicles while minimizing damage to surrounding skin tissue.

This device is intended for office-based use by trained professionals in dermatology or cosmetic surgery settings. Supplied as a reusable medical laser system, it requires proper training for operation and maintenance. The Iriderm, Model Apex 800 holds FDA 510(k) clearance (K992298) under the Traditional 510(k) pathway, with a decision date of December 9, 1999. No specific sterility or single-use designation is stated in the regulatory data.

Frequently asked questions

What is the Iriderm Apex 800 used for?

The Iriderm Apex 800 is a laser hair removal system designed specifically for reducing hair growth in patients with pigmented hair follicles. It delivers controlled laser energy to target follicles while minimizing damage to surrounding skin tissue, making it suitable for dermatologists and cosmetic surgeons in office settings.

Is the Iriderm Apex 800 single-use or reusable?

The Iriderm Apex 800 is supplied as a reusable medical laser system. It requires proper training for operation and maintenance, as it is intended for repeated use in clinical environments by trained professionals.

What regulatory clearance does the Iriderm Apex 800 hold?

The Iriderm Apex 800 holds FDA 510(k) clearance under the Traditional 510(k) pathway, with clearance number K992298. This classification confirms it is substantially equivalent to a legally marketed device and is authorized for use in the United States.

Where can the Iriderm Apex 800 be used?

This device is intended for office-based use by trained professionals in dermatology or cosmetic surgery settings. It is not designed for home use or unsupervised application.

Does the Iriderm Apex 800 require special handling or storage?

While the device itself is reusable, its use requires adherence to standard laser safety protocols, including proper training for operators. Specific storage instructions are not detailed in the regulatory data, but it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain functionality and safety.

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: IRIDERM, MODEL APEX 800 (K992298) — FDA 510 (k) | Innolitics, APEX 800 LASER SYSTEM, MODEL APEX 800 (K020849) — FDA 510(k) | Innolitics, Iridex Corp FDA 510 (k) Products (1998-2012), IRIDEX Corp. - HairFacts | Hair Removal Information

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Iridex Corp

Sources (1)

  • FDA 510(k) K992298 24 fields · synced Oct 1, 2026