Question 1

Who is the manufacturer of NIIC LASER SYSTEM?

Accepted Answer

Niic U.S.A., Inc. filed the 510(k) submission for NIIC LASER SYSTEM (K896988).

Question 2

What is the FDA product code for NIIC LASER SYSTEM?

Accepted Answer

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was NIIC LASER SYSTEM cleared by the FDA?

Accepted Answer

Jan 23, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for NIIC LASER SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NIIC LASER SYSTEM?

Accepted Answer

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.

Record ID	K896988
Device Name	NIIC LASER SYSTEM
Applicant	Niic U.S.A., Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Jan 23, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2

NIIC LASER SYSTEM

Device Facts

Regulatory Classification

Identification