510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864510Substantially Equivalent

Psoralite 12800 Series

Psoralite Corp., Columbia SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864510 is the FDA 510(k) clearance record for PSORALITE 12800 SERIES, a class II device, cleared for Psoralite Corp. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 5 510(k) clearances for Psoralite Corp., from to . As of , FDA records show no recalls naming K864510.

Clearance record

Decision date
Received
(82 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Psoralite Corp. 1401 Pineview Dr., Columbia SC
Third party review
No

Clearances, product code FTC

Trailing 12 months
2 clearances under product code FTC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260