Question 1

Who is the manufacturer of PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT?

Accepted Answer

Psoralite Corp. filed the 510(k) submission for PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT (K913760).

Question 2

What is the FDA product code for PSORALITE , PHOTOTHERAPY TREATMENT 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 PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT cleared by the FDA?

Accepted Answer

Oct 28, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PSORALITE , PHOTOTHERAPY TREATMENT 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	K913760
Device Name	PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
Applicant	Psoralite Corp.
Product Code	FTC · General, Plastic Surgery
Decision Date	Oct 28, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4630
Device Class	Class 2

PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT

Device Facts

Regulatory Classification

Identification