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FDA 510(k)

ClearLink Controlled Phototherapy Equipment

K-Number: K182215 · 2018-10-29

ApplicantDaavlin Distributing Company
Decision Date2018-10-29
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ClearLink Controlled Phototherapy Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Company. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K182215. 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 ClearLink Controlled Phototherapy Equipment?

ClearLink Controlled Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Daavlin Distributing Company. The 510(k) number is K182215.

When did ClearLink Controlled Phototherapy Equipment receive FDA 510(k) clearance?

ClearLink Controlled Phototherapy Equipment received FDA 510(k) clearance on 2018-10-29, under 510(k) number K182215.

Who is the listed applicant for ClearLink Controlled Phototherapy Equipment?

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

What is the FDA product code for ClearLink Controlled Phototherapy Equipment?

The FDA product code for ClearLink Controlled Phototherapy Equipment is FTC.

Other records listing Daavlin Distributing Company 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.

K233811DT Controlled Phototherapy EquipmentK2303823 Series NeoLuxK2208401 Series Phototherapy EquipmentK2125107 Series Phototherapy DeviceK210881M Series Phototherapy EquipmentK1537493 Series Phototherapy Unit

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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

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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