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FDA 510(k)

BIOFLEX LD-R100 TREATMENT HEAD

K-Number: K081355 · 2008-12-18

ApplicantMeditech International, Inc.
Decision Date2008-12-18
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOFLEX LD-R100 TREATMENT HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Meditech International, Inc.. It received FDA 510(k) clearance on 2008-12-18 under 510(k) number K081355. 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 BIOFLEX LD-R100 TREATMENT HEAD?

BIOFLEX LD-R100 TREATMENT HEAD is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Meditech International, Inc.. The 510(k) number is K081355.

When did BIOFLEX LD-R100 TREATMENT HEAD receive FDA 510(k) clearance?

BIOFLEX LD-R100 TREATMENT HEAD received FDA 510(k) clearance on 2008-12-18, under 510(k) number K081355.

Who is the listed applicant for BIOFLEX LD-R100 TREATMENT HEAD?

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

What is the FDA product code for BIOFLEX LD-R100 TREATMENT HEAD?

The FDA product code for BIOFLEX LD-R100 TREATMENT HEAD is ILY.

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Other records listing Meditech International, Inc. 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.

K072551LD-I 75 AND LD-I 200K051875BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADSK041885BIOFLEX LD-175 AND LD-1200 TREATMENT HEADSK023621BIOFLEX PROFESSIONAL THERAPY SYSTEM

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

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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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