Question 1

Who is the manufacturer of SUNTANNING EQUIPMENT?

Accepted Answer

Oakport Intl., Inc. filed the 510(k) submission for SUNTANNING EQUIPMENT (K851532).

Question 2

What is the FDA product code for SUNTANNING EQUIPMENT?

Accepted Answer

FTC. It is classified under 21 CFR 878.4630 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was SUNTANNING EQUIPMENT cleared by the FDA?

Accepted Answer

May 7, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for SUNTANNING EQUIPMENT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SUNTANNING EQUIPMENT?

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	K851532
Device Name	SUNTANNING EQUIPMENT
Applicant	Oakport Intl., Inc.
Product Code	FTC · General, Plastic Surgery
Decision Date	May 7, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4630
Device Class	Class 2

SUNTANNING EQUIPMENT

Device Facts

Regulatory Classification

Identification