FDA 510(k)

SKIN-LITE

K-Number: K843300 · 1984-11-07

Decision Date1984-11-07

Product CodeKMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SKIN-LITE is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Chemical. It received FDA 510(k) clearance on 1984-11-07 under 510(k) number K843300. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN-LITE?

SKIN-LITE is a medical device that received FDA 510(k) clearance on 1984-11-07. The listed applicant is Guardian Chemical. The 510(k) number is K843300.

When did SKIN-LITE receive FDA 510(k) clearance?

SKIN-LITE received FDA 510(k) clearance on 1984-11-07, under 510(k) number K843300.

Who is the listed applicant for SKIN-LITE?

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

What is the FDA product code for SKIN-LITE?

The FDA product code for SKIN-LITE is KMF.

Other records listing Guardian Chemical 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.

K834455MONOXYCHLOROSENE WAREXIN

Related Devices (Code: KMF)

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLC K171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC K120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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.