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FDA 510(k)

LASER SKIN MARKER AND MASK WHITE LOTION

K-Number: K861772 · 1986-05-21

ApplicantPacific Poly Crafts
Decision Date1986-05-21
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER SKIN MARKER AND MASK WHITE LOTION is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Poly Crafts. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K861772. The device is classified under product code FZZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER SKIN MARKER AND MASK WHITE LOTION?

LASER SKIN MARKER AND MASK WHITE LOTION is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Pacific Poly Crafts. The 510(k) number is K861772.

When did LASER SKIN MARKER AND MASK WHITE LOTION receive FDA 510(k) clearance?

LASER SKIN MARKER AND MASK WHITE LOTION received FDA 510(k) clearance on 1986-05-21, under 510(k) number K861772.

Who is the listed applicant for LASER SKIN MARKER AND MASK WHITE LOTION?

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

What is the FDA product code for LASER SKIN MARKER AND MASK WHITE LOTION?

The FDA product code for LASER SKIN MARKER AND MASK WHITE LOTION is FZZ.

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

Related Devices (Code: FZZ)

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.

K042555SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.K915066DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the BlindK905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, 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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