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FDA 510(k)

SUN CAPSULE I & II SUNTANNING BOOTH

K-Number: K871237 · 1987-04-23

ApplicantSun Capsule, Inc.
Decision Date1987-04-23
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUN CAPSULE I & II SUNTANNING BOOTH is the device name listed in this FDA 510(k) record. The listed applicant is Sun Capsule, Inc.. It received FDA 510(k) clearance on 1987-04-23 under 510(k) number K871237. 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 SUN CAPSULE I & II SUNTANNING BOOTH?

SUN CAPSULE I & II SUNTANNING BOOTH is a medical device that received FDA 510(k) clearance on 1987-04-23. The listed applicant is Sun Capsule, Inc.. The 510(k) number is K871237.

When did SUN CAPSULE I & II SUNTANNING BOOTH receive FDA 510(k) clearance?

SUN CAPSULE I & II SUNTANNING BOOTH received FDA 510(k) clearance on 1987-04-23, under 510(k) number K871237.

Who is the listed applicant for SUN CAPSULE I & II SUNTANNING BOOTH?

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

What is the FDA product code for SUN CAPSULE I & II SUNTANNING BOOTH?

The FDA product code for SUN CAPSULE I & II SUNTANNING BOOTH is FTC.

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

Other records listing Sun Capsule, 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.

K152238Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5

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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