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FDA 510(k)

VERSA LITE

K-Number: K073503 · 2008-01-23

ApplicantDiomedics, Inc.
Decision Date2008-01-23
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERSA LITE is the device name listed in this FDA 510(k) record. The listed applicant is Diomedics, Inc.. It received FDA 510(k) clearance on 2008-01-23 under 510(k) number K073503. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSA LITE?

VERSA LITE is a medical device that received FDA 510(k) clearance on 2008-01-23. The listed applicant is Diomedics, Inc.. The 510(k) number is K073503.

When did VERSA LITE receive FDA 510(k) clearance?

VERSA LITE received FDA 510(k) clearance on 2008-01-23, under 510(k) number K073503.

Who is the listed applicant for VERSA LITE?

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

What is the FDA product code for VERSA LITE?

The FDA product code for VERSA LITE is FTC.

Related Clinical Trials

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Other records listing Diomedics, 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.

K982546PHASER-2000K926224DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

Related Devices (Code: FTC)

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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

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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