510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K020591Substantially Equivalent

Bclear

Lumenis Ltd, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020591 is the FDA 510(k) clearance record for BCLEAR, a class II device, cleared for Lumenis on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 83 510(k) clearances for Lumenis, from to . As of , FDA records show no recalls naming K020591.

Clearance record

Decision date
Received
(83 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lumenis 1249 Quarry Ln., Suite 100, Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTC

Trailing 12 months
4 clearances under product code FTC in the twelve months to November 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FTC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20262
November 20260