Question 1

Who is the manufacturer of KTP/532 SURGICAL LASER?

Accepted Answer

Laserscope filed the 510(k) submission for KTP/532 SURGICAL LASER (K884029).

Question 2

What is the FDA product code for KTP/532 SURGICAL LASER?

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 KTP/532 SURGICAL LASER cleared by the FDA?

Accepted Answer

Nov 25, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for KTP/532 SURGICAL LASER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like KTP/532 SURGICAL LASER?

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	K884029
Device Name	KTP/532 SURGICAL LASER
Applicant	Laserscope
Product Code	GEX · General, Plastic Surgery
Decision Date	Nov 25, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2

KTP/532 SURGICAL LASER

Device Facts

Regulatory Classification

Identification