Cleared Traditional

K031828 - NATURALASE LP ND:YAG LASER

K031828 is an FDA 510(k) clearance for NATURALASE LP ND:YAG LASER, manufactured by Focus Medical, LLC. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K031828 · Focus Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
34d
Days
Class 1
Risk

K031828 is an FDA 510(k) clearance for the NATURALASE LP ND:YAG LASER. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Focus Medical, LLC (Bethel, US). The FDA issued a Cleared decision on July 17, 2003 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Focus Medical, LLC devices

FDA 510(k) Submission Details - K031828

510(k) Number K031828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

Product Code GEN Forceps, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GEN Forceps, General & Plastic Surgery

All 66
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K031828.
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
GS-1200 GRASPING/EXTRACTING FORCEP, 10MM
K900952 · Solos Endoscopy, Inc. · Apr 1990
GS-1500 CLAW FORCEP, 10MM
K900960 · Solos Endoscopy, Inc. · Apr 1990
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989