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 a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2022-02-04 under approval 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. It is manufactured by Lutronic Corporation. The 510(k) number is K213569.
When was HOLLYWOOD SPECTRA Laser System approved by the FDA?
HOLLYWOOD SPECTRA Laser System received FDA 510(k) clearance on 2022-02-04, under approval number K213569.
What company makes HOLLYWOOD SPECTRA Laser System?
HOLLYWOOD SPECTRA Laser System is manufactured by Lutronic Corporation.
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.
Related Clinical Trials
NCT07607496
MacuTherm Performance Study in Patients With iAMD
NOT_YET_RECRUITING
NCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
RECRUITING
NCT07214220
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
RECRUITING
NCT07580560
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study
COMPLETED
NCT06795451
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
RECRUITING
NCT07340671
Facial Papules in Frontal Fibrosing Alopecia (FFA)
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 40624055
Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery.
Scientific reports (2025)
PMID: 40407411
A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology.
JASA express letters (2025)
Other Devices by Lutronic Corporation
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.