FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 1 results

510(k) Data Aggregation

K Number

Device Name

SCAR HEAL

Manufacturer

SPECIALTY SYSTEMS, INC.

Date Cleared

1997-06-10

(49 days)

Product Code

MDA

Regulation Number

878.4025

Why did this record match?

Applicant Name (Manufacturer) :

SPECIALTY SYSTEMS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Hypertuophie Scars Keloid Scars

Device Description

Not Found

Ask a Question

Page 1 of 1