Question 1

Who is the manufacturer of ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER?

Accepted Answer

Heraeus Lasersonics, Inc. filed the 510(k) submission for ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER (K896517).

Question 2

What is the FDA product code for ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER?

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 ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER cleared by the FDA?

Accepted Answer

Feb 9, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER?

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	K896517
Device Name	ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER
Applicant	Heraeus Lasersonics, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Feb 9, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2

ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER

Device Facts

Regulatory Classification

Identification