FDA 510(k) Search

K Number

K251149

Device Name

AviClear Laser System

Manufacturer

Cutera, Inc.

Date Cleared

2025-07-11

Product Code

GEX

Regulation Number

878.4810

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Summary

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