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FDA 510(k)

SOLOS EYESITE DRAPES

K-Number: K872620 · 1987-07-31

ApplicantSolos Ophthalmology
Decision Date1987-07-31
Product CodeHMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOLOS EYESITE DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Solos Ophthalmology. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K872620. The device is classified under product code HMT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOS EYESITE DRAPES?

SOLOS EYESITE DRAPES is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Solos Ophthalmology. The 510(k) number is K872620.

When did SOLOS EYESITE DRAPES receive FDA 510(k) clearance?

SOLOS EYESITE DRAPES received FDA 510(k) clearance on 1987-07-31, under 510(k) number K872620.

Who is the listed applicant for SOLOS EYESITE DRAPES?

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

What is the FDA product code for SOLOS EYESITE DRAPES?

The FDA product code for SOLOS EYESITE DRAPES is HMT.

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 Solos Ophthalmology 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.

K874334SOLOS SINGLE USE TITANIUM TIPK872611SOLOS EYESITE CAP SLEEVEK872610SOLOS EYESITE CANNULASK872612SOLOS EYESITE SPONGES

Related Devices (Code: HMT)

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.

K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEVisitec Co.K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.K871706OPTHA PREPTreace Medical, Inc.K854613SURGICAL DRAPES, OPHTHALMINCharles Atkins & Co.K831340DRAIN-R-DRAPE(EYESur-Tech, Inc.K830822EYE DRAPECooperVision, Inc.

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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