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

TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER

Manufacturer

LUMEN DEVELOPMENT AND MANUFACTURING, INC.

Date Cleared

2007-12-18

(56 days)

Product Code

GEX

Regulation Number

878.4810

Why did this record match?

Applicant Name (Manufacturer) :

LUMEN DEVELOPMENT AND MANUFACTURING, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1