Question 1

Who is the manufacturer of LPI YAG MODEL 1003 SURGICAL LASER SYSTEM?

Accepted Answer

Laser Photonics, Inc. filed the 510(k) submission for LPI YAG MODEL 1003 SURGICAL LASER SYSTEM (K900837).

Question 2

What is the FDA product code for LPI YAG MODEL 1003 SURGICAL 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 LPI YAG MODEL 1003 SURGICAL LASER SYSTEM cleared by the FDA?

Accepted Answer

Jul 12, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for LPI YAG MODEL 1003 SURGICAL LASER SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LPI YAG MODEL 1003 SURGICAL 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	K900837
Device Name	LPI YAG MODEL 1003 SURGICAL LASER SYSTEM
Applicant	Laser Photonics, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Jul 12, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2

LPI YAG MODEL 1003 SURGICAL LASER SYSTEM

Device Facts

Regulatory Classification

Identification