Who is the manufacturer of ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY?

Surgilase, Inc. filed the 510(k) submission for ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY (K875042).

What is the FDA product code for ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY?

LKW. as a Class 3 device in the NE panel.

What is the regulatory pathway for ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY

K875042 · Surgilase, Inc. · LKW · Jun 24, 1988 · NE

Device Facts

Record ID	K875042
Device Name	ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
Applicant	Surgilase, Inc.
Product Code	LKW · NE
Decision Date	Jun 24, 1988
Decision	SESE
Submission Type	Traditional
Device Class	Class 3

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