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FDA 510(k)

MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET

K-Number: K894558 · 1989-08-07

ApplicantOptik
Decision Date1989-08-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET is the device name listed in this FDA 510(k) record. The listed applicant is Optik. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K894558. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET?

MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Optik. The 510(k) number is K894558.

When did MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET receive FDA 510(k) clearance?

MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET received FDA 510(k) clearance on 1989-08-07, under 510(k) number K894558.

Who is the listed applicant for MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET?

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

What is the FDA product code for MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET?

The FDA product code for MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET is HRX.

Related Clinical Trials

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Other records listing Optik 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.

K933776OPTIK LAPAROSCOPEK926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMK896404TITAMED ANTWERP SYSTEMK896589MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERPK894557LIGHTSCOPE SET

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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