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)

BACK-TEK

K-Number: K101227 · 2010-06-23

ApplicantYork Biomedical, Inc.
Decision Date2010-06-23
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BACK-TEK is the device name listed in this FDA 510(k) record. The listed applicant is York Biomedical, Inc.. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K101227. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACK-TEK?

BACK-TEK is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is York Biomedical, Inc.. The 510(k) number is K101227.

When did BACK-TEK receive FDA 510(k) clearance?

BACK-TEK received FDA 510(k) clearance on 2010-06-23, under 510(k) number K101227.

Who is the listed applicant for BACK-TEK?

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

What is the FDA product code for BACK-TEK?

The FDA product code for BACK-TEK is ILY.

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, 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.

↑