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

FENCER 308 EXCIMER LASER SYSTEM

Manufacturer

KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP

Date Cleared

2008-07-15

(99 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

The Fencer 308 Excimer Laser will be indicated for use the Psoriasis, vitiligo, atopic dermatitis and leukoderma.

Device Description

Not Found

Ask a Question

Ask a specific question about this device

Page 1 of 1