Booth, Sun Tan

Device Code: 5723

Product Code(s): LEJ

Device Type ID	5723
Device Name	Booth, Sun Tan
Regulation Description	Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products.
Regulation Medical Specialty	General & Plastic Surgery
Review Panel	General & Plastic Surgery
Premarket Review	Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type	510(k)
CFR Regulation Number	878.4635 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	LEJ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	5723
Device	Booth, Sun Tan
Product Code	LEJ
FDA Device Classification	Class 2 Medical Device
Regulation Description	Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products.
CFR Regulation Number	878.4635 [🔎]

Premarket Reviews
Manufacturer	Decision
BLV LICHT-UND VAKUUMTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
HEARTLAND TANNING, INC.
	SUBSTANTIALLY EQUIVALENT	1
IBL ACQUISITIONS LLC
	SUBSTANTIALLY EQUIVALENT	1
J.W. HOLDING GMBH
	SUBSTANTIALLY EQUIVALENT	3
JK HOLDING GMBH
	SUBSTANTIALLY EQUIVALENT	2
KBL AG
	SUBSTANTIALLY EQUIVALENT	1
LIGHT SOURCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
LPI, INC.
	SUBSTANTIALLY EQUIVALENT	1
PC MARKETING, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPORTARREDO GROUP S.C.
	SUBSTANTIALLY EQUIVALENT	2
SUN CAPSULE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SUNFIRE INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Electrical Overstress	8
Inadequate Or Insufficient Training	1
Improper Or Incorrect Procedure Or Method	1
Fire	1
Electrical /Electronic Property Problem	1
Use Of Device Problem	1
Total Device Problems	13

TPLC Last Update: 2019-04-02 21:11:27