Cleared Traditional

K073300 - MILESMAN PREMIUM

K073300 is an FDA 510(k) clearance for MILESMAN PREMIUM, manufactured by Milesman S.L.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K073300 · Milesman S.L. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
11d
Days
Class 2
Risk

K073300 is an FDA 510(k) clearance for the MILESMAN PREMIUM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Milesman S.L. (Great Neck, US). The FDA issued a Cleared decision on December 4, 2007 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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.

FDA 510(k) Submission Details - K073300

510(k) Number K073300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2007
Decision Date December 04, 2007
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2836
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K073300.
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
K072995 · Lumen Development and Manufacturing, Inc. · Dec 2007
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
K073409 · Omniguide, Inc. · Dec 2007
SMARTLIPO LASER
K073394 · Cynosure, Inc. · Dec 2007
APL MEDICAL SYSTEM
K072344 · Bios S.R.L. · Dec 2007
NOVEON, MODEL LS1100-01-0968
K071815 · Nomir Medical Technologies, Inc. · Nov 2007
ERBIUM FRACTIONAL HANDPIECE
K071768 · Palomar Medical Products, Inc. · Nov 2007

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K073300 · MILESMAN PREMIUM
Download PDF FDA Summary Milesman S.L.