Panels › General, Plastic Surgery › Product code FTC · Class 2

Light, Ultraviolet, Dermatological

Regulation 878.4630

4510(k)s in 12 months (274 all time)

4recalls in 12 months (15 all time)

10recalls that name a 510(k)

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Top companies in FTC

Company	510(k)s	Recalls
National Biological Corp.	27	4
Daavlin Distributing Co.	17	11
Philips Int'L B.V.	9	0
Light Sources, Inc.	8	0
Mottek Intl. Corp.	8	0
Avex Industries , Ltd.	6	0
Philips Lighting Co.	6	0
Psoralite Corp.	5	0
Tannhut	5	0
Medical Device Consultants, Inc.	4	0

Date	Firm and product	Code	Linked 510(k)
Jul 15, 2026	Daavlin Distributing Company Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified	FTC	K182215
Jul 15, 2026	Daavlin Distributing Company Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified	FTC	K212510
Jul 15, 2026	Daavlin Distributing Company Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified	FTC	K210881
Jun 2, 2026	Daavlin Distributing Company Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physici Open, Classified	FTC	K220840
Apr 26, 2022	Daavlin Distributing Company 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6. Open, Classified	FTC	K111172
Apr 26, 2022	Daavlin Distributing Company 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120 Open, Classified	FTC	K100378
Mar 20, 2017	National Biological Corp Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment. Terminated	FTC	K872604
Jul 19, 2013	National Biological Corp Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vit Terminated	FTC	K903660
Jul 19, 2013	National Biological Corp Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vi Terminated	FTC	K903660
Aug 28, 2008	National Biological Corp HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy Terminated	FTC	K041212
Jul 30, 2004	Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048. Terminated	FTC	None listed
Jul 30, 2004	Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048. Terminated	FTC	None listed
Jul 30, 2004	Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #LNBH-0048. Terminated	FTC	None listed
Jul 30, 2004	Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model All Touch Control System, Model #ASNBSM-2424 units manufactured between 6/5/03 and 4/30/04.. Terminated	FTC	None listed
Jul 30, 2004	Daavlin Distributing Company 3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424. Terminated	FTC	None listed

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