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Found 2 results

510(k) Data Aggregation

K Number

Device Name

LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER

Manufacturer

HERAEUS SURGICAL, INC.

Date Cleared

1996-08-21

(189 days)

Product Code

GEX

Regulation Number

878.4810

Why did this record match?

Applicant Name (Manufacturer) :

HERAEUS SURGICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd: YAG soft tissue applications.

Device Description

Cylindrically Diffusing Sterile Disposable Fiber

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K Number

Device Name

LASERSONICS PARASCAN DOSIMETER DEVICE

Manufacturer

HERAEUS SURGICAL, INC.

Date Cleared

1996-02-13

(57 days)

Product Code

GEX

Regulation Number

878.4810

Why did this record match?

Applicant Name (Manufacturer) :

HERAEUS SURGICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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