Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aurolase Therapy, Laser Delivery Device (LDD)

K-Number: K202953 · 2022-10-03

ApplicantNanospectra Biosciences, Inc.
Decision Date2022-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aurolase Therapy, Laser Delivery Device (LDD) is a medical device manufactured by Nanospectra Biosciences, Inc.. It received FDA 510(k) clearance on 2022-10-03 under approval number K202953. 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 Aurolase Therapy, Laser Delivery Device (LDD)?

Aurolase Therapy, Laser Delivery Device (LDD) is a medical device that received FDA 510(k) clearance on 2022-10-03. It is manufactured by Nanospectra Biosciences, Inc.. The 510(k) number is K202953.

When was Aurolase Therapy, Laser Delivery Device (LDD) approved by the FDA?

Aurolase Therapy, Laser Delivery Device (LDD) received FDA 510(k) clearance on 2022-10-03, under approval number K202953.

What company makes Aurolase Therapy, Laser Delivery Device (LDD)?

Aurolase Therapy, Laser Delivery Device (LDD) is manufactured by Nanospectra Biosciences, Inc..

What is the FDA product code for Aurolase Therapy, Laser Delivery Device (LDD)?

The FDA product code for Aurolase Therapy, Laser Delivery Device (LDD) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07615361 Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy ENROLLING_BY_INVITATION NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT07615920 HILT vs ESWT in Supraspinatus Tendinitis NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

Other Devices by Nanospectra Biosciences, Inc.

K243701AuroLase® System

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.

↑