510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031828Substantially Equivalent

Naturalase Lp Nd:yag Laser

Focus Medical, LLC., Bethel CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031828 is the FDA 510(k) clearance record for NATURALASE LP ND:YAG LASER, a class I device, cleared for Focus Medical, LLC on under FDA product code GEN (Forceps, General & Plastic Surgery). FDA records list 10 510(k) clearances for Focus Medical, LLC, from to . As of , FDA records show no recalls naming K031828.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GEN Forceps, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Focus Medical, LLC 23 Francis J Clarke Cir., Bethel CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEN

Trailing 12 months

FDA records hold no clearances under product code GEN in the trailing twelve months.

FDA records show no clearances under product code GEN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260