Cleared Traditional

K131757 - TATTOOSTAR EFFECT COMBO

K131757 is an FDA 510(k) clearance for TATTOOSTAR EFFECT COMBO, manufactured by Asclepion Laser Technologies GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K131757 · Asclepion Laser Technologies GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
395d
Days
Class 2
Risk

K131757 is an FDA 510(k) clearance for the TATTOOSTAR EFFECT COMBO. 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 Asclepion Laser Technologies GmbH (Jena, Thuringia, DE). The FDA issued a Cleared decision on July 17, 2014 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Asclepion Laser Technologies GmbH devices

FDA 510(k) Submission Details - K131757

510(k) Number K131757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date July 17, 2014
Days to Decision 395 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
280d slower than avg
Panel avg: 115d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - GEX Powered Laser Surgical Instrument

All 2213
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K131757.
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
K141838 · Regulatory Technology Services, LLC · Jul 2014
PICOSURE WORKSTATION
K133364 · Cynosure, Inc. · Jul 2014
ALMA DIODE TABLETOP LASER
K140005 · Alma Lasers , Ltd. · Jul 2014
LINSCAN 808, LINSCAN 980
K141063 · Gme (German Medical Engineering) GmbH · Jul 2014
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
K132806 · Fotona D.D. · Jul 2014
SUREFLEX LITHOTRIPSY LASER FIBERS
K140679 · American Medical Systems · Jun 2014