Cleared Traditional

NATURALASE LP ND:YAG LASER

K031828 · Focus Medical, LLC · General & Plastic Surgery
Jul 2003
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K031828 is an FDA 510(k) clearance for the NATURALASE LP ND:YAG LASER, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Focus Medical, LLC (Bethel, US). The FDA issued a Cleared decision on July 17, 2003, 34 days after receiving the submission on June 13, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K031828 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2003
Decision Date July 17, 2003
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

Similar Devices — GEN Forceps, General & Plastic Surgery

All 103
FORCEPS
K953962 · Biopsys Medical, Inc. · Sep 1995
SUTURE REMOVING FORCEPS
K932385 · Rocket of London, Ltd. · Aug 1993
FORCEPS
K904723 · Minto Research & Development, Inc. · Jul 1991
PALPATION PROBE
K911159 · Northgate Technologies, Inc. · Mar 1991
GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
K900948 · Solos Endoscopy, Inc. · Apr 1990
GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP
K900951 · Solos Endoscopy, Inc. · Apr 1990