Question 1

Who is the manufacturer of KAVO K.E.Y. LASER 1242?

Accepted Answer

Kavo America filed the 510(k) submission for KAVO K.E.Y. LASER 1242 (K000805).

Question 2

What is the FDA product code for KAVO K.E.Y. LASER 1242?

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 KAVO K.E.Y. LASER 1242 cleared by the FDA?

Accepted Answer

May 4, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for KAVO K.E.Y. LASER 1242?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like KAVO K.E.Y. LASER 1242?

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	K000805
Device Name	KAVO K.E.Y. LASER 1242
Applicant	Kavo America
Product Code	GEX · General, Plastic Surgery
Decision Date	May 4, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2

KAVO K.E.Y. LASER 1242

Device Facts

Regulatory Classification

Identification