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FDA 510(k)

PicoLazer Laser System

K-Number: K192583 · 2020-01-17

ApplicantRohrer Aesthetics, LLC
Decision Date2020-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PicoLazer Laser System is a medical device manufactured by Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2020-01-17 under approval number K192583. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PicoLazer Laser System?

PicoLazer Laser System is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Rohrer Aesthetics, LLC. The 510(k) number is K192583.

When was PicoLazer Laser System approved by the FDA?

PicoLazer Laser System received FDA 510(k) clearance on 2020-01-17, under approval number K192583.

What company makes PicoLazer Laser System?

PicoLazer Laser System is manufactured by Rohrer Aesthetics, LLC.

What is the FDA product code for PicoLazer Laser System?

The FDA product code for PicoLazer Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Rohrer Aesthetics, LLC

K180654PINXEL-RF system K191162EpiLaze Multi-wavelength Laser K212331BodySculp K210535UltraLight LED System K233099Gladiator

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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