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510(k) Data Aggregation

K Number

K152436

Validate with FDA (Live)

Device Name

Suntanning Lamps

Manufacturer

Interlectric Corporation

Date Cleared

2015-12-07

(102 days)

Product Code

LEJ

Regulation Number

878.4635

Type

Traditional

Panel

General & Plastic Surgery

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Suntanning Lamps used to tan the skin

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for "Suntanning Lamps" (K152436) does not contain any information about acceptance criteria, device performance, or any studies conducted.

The document is a standard clearance letter stating that the device is substantially equivalent to a predicate device and outlining regulatory responsibilities. It does not include data from performance testing or clinical studies.

Therefore, I cannot provide the requested information based on this document.

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