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FDA 510(k)

HOLLYWOOD SPECTRA Laser System

K-Number: K213569 · 2022-02-04

ApplicantLutronic Corporation
Decision Date2022-02-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HOLLYWOOD SPECTRA Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213569. 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 HOLLYWOOD SPECTRA Laser System?

HOLLYWOOD SPECTRA Laser System is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Lutronic Corporation. The 510(k) number is K213569.

When did HOLLYWOOD SPECTRA Laser System receive FDA 510(k) clearance?

HOLLYWOOD SPECTRA Laser System received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213569.

Who is the listed applicant for HOLLYWOOD SPECTRA Laser System?

The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLYWOOD SPECTRA Laser System?

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

Other records listing Lutronic Corporation as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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