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

FDA 510(k)

MELANITE I

K-Number: K872506 · 1987-07-27

ApplicantAura Lens Products
Decision Date1987-07-27
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MELANITE I is the device name listed in this FDA 510(k) record. The listed applicant is Aura Lens Products. It received FDA 510(k) clearance on 1987-07-27 under 510(k) number K872506. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MELANITE I?

MELANITE I is a medical device that received FDA 510(k) clearance on 1987-07-27. The listed applicant is Aura Lens Products. The 510(k) number is K872506.

When did MELANITE I receive FDA 510(k) clearance?

MELANITE I received FDA 510(k) clearance on 1987-07-27, under 510(k) number K872506.

Who is the listed applicant for MELANITE I?

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

What is the FDA product code for MELANITE I?

The FDA product code for MELANITE I is HQG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aura Lens Products as applicant

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.

K852403AURALITE II

Related Devices (Code: HQG)

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.

K935919SUNGLASSESJa-Ru, Inc.K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXOptical Radiation Corp.K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOROnufryk Low Vision Ent.K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSESSeiko Corp.K882814NEOLENS PRESCRIPTION SPECTACLE LENSNeolens, Inc.K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens System

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.

↑