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)

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

K-Number: K061295 · 2006-05-25

ApplicantTheralight, Inc.
Decision Date2006-05-25
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Theralight, Inc.. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K061295. 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 VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100?

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Theralight, Inc.. The 510(k) number is K061295.

When did VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 receive FDA 510(k) clearance?

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 received FDA 510(k) clearance on 2006-05-25, under 510(k) number K061295.

Who is the listed applicant for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100?

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

What is the FDA product code for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100?

The FDA product code for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 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 Theralight, 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.

K051259VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100K024020THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEMK022165THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2

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.

↑