FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT

Light, Ultraviolet, Dermatological

DAAVLIN DISTRIBUTING CO.

The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Flex Controlled Phototherapy Equipment.

Pre-market Notification Details

• Device ID: K050695
• 510k Number: K050695
• Device Name: FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
• Classification: Light, Ultraviolet, Dermatological
• Applicant: DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506
• Contact: David W Swanson
• Correspondent: David W Swanson; DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506
• Product Code: FTC
• CFR Regulation Number: 878.4630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-18
• Decision Date: 2005-04-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B2809861PH2424X6	K050695	000
B280809HO1200CT506	K050695	000
B280809HO1200CX50	K050695	000
B280811UV0028CX5E01	K050695	000
B280811UV2800CX6E02	K050695	000
B280862NL0040MMCT05	K050695	000
B280862NL0040MMCT3P0	K050695	000
B280862NL0040PCCT0	K050695	000
B280862NL2020MMCT05	K050695	000
B280862NL2020MMCT3P0	K050695	000
B280862NL4000MMCT05	K050695	000
B280862NL4000MMCT3P0	K050695	000
B280809HO1000CX609	K050695	000
B280809HO1000CX508	K050695	000
B2809861PH4800T5	K050695	000
B2809801MI0010CX600	K050695	000
B280808HO0004CT5ND0	K050695	000
B280808HO0004CX50	K050695	000
B280808HO0004CX5N03	K050695	000
B280808HO0004CX5ND03	K050695	000
B280808HO0006CT508	K050695	000
B280808HO0006CX50	K050695	000
B280808HO0006CX5ND05	K050695	000
B280808HO0010CT503	K050695	000
B280809HO1000CT504	K050695	000
B280862NL4000PCCT0	K050695	000
B280862NL4000PCCT3P0	K050695	000
B280864NL4000MMCT07	K050695	000
B280808HO0004CX60	K050695	000
B280808HO0004CX6ND04	K050695	000
B280808HO0006CT5ND01	K050695	000
B280808HO0008CT50	K050695	000
B280808HO0008CT60	K050695	000
B280808HO0008CX50	K050695	000
B280808HO0008CX60	K050695	000
B280808HO0010CT604	K050695	000
B280808HO0010CX507	K050695	000
B280808HO0010CX608	K050695	000
B280808HO0012CT505	K050695	000
B280808HO0004CT6ND00	K050695	000
B280808HO0004CT607	K050695	000
B280864NL4000PCCT00	K050695	000
B280864NL4800MMCT0	K050695	000
B280864NL4800PCCT08	K050695	000
B280864NL2020MMCT0	K050695	000
B280801MI0010CX50	K050695	000
B280801MI0010CX600	K050695	000
B280801MI0604CX508	K050695	000
B280801MI0604CX609	K050695	000
B280801MI1000CX50	K050695	000
B280801MI1000CX600	K050695	000
B280808HO0004CT506	K050695	000
B280808HO0012CX509	K050695	000
B2809801MI0010T5	K050695	000
B2809803MI0010T6	K050695	000
B2809803MI0010X6100	K050695	000
B2809803MI0604T6	K050695	000
B2809803MI0604X6100	K050695	000
B2809808HO0004T6	K050695	000
B2809808HO0004T60	K050695	000
B2809808HO0004X5	K050695	000
B2809808HO0004X6	K050695	000
B2809808HO0006T5	K050695	000
B2809808HO0006T6	K050695	000
B2809808HO0006X5	K050695	000
B2809801MI1000X6	K050695	000
B2809801MI1000X5	K050695	000
B2809801MI0010T6	K050695	000
B2809801MI0010X5	K050695	000
B2809801MI0010X6	K050695	000
B2809801MI0406X5	K050695	000
B2809801MI0406X6	K050695	000
B2809801MI0604T5	K050695	000
B2809801MI0604T6	K050695	000
B2809801MI0604X5	K050695	000
B2809801MI0604X6	K050695	000
B2809801MI1000T5	K050695	000
B2809801MI1000T6	K050695	000
B2809808HO0006X6	K050695	000
B2809808HO0008T5	K050695	000
B2809808HO0008T6	K050695	000
B2809809HO0012T60	K050695	000
B2809809HO0800T6	K050695	000
B2809809HO0800X6	K050695	000
B2809809HO1000CX6	K050695	000
B2809809HO1000T6	K050695	000
B2809809HO1200T6	K050695	000
B2809809HO1200T60	K050695	000
B2809809HO1200X6	K050695	000
B2809861PH0024X6	K050695	000
B2809861PH0048X5	K050695	000
B2809861PH0048X6	K050695	000
B2809809HO0008X604	K050695	000
B2809809HO0008T600	K050695	000
B2809808HO0008X5	K050695	000
B2809808HO0008X6	K050695	000
B2809808HO0010T5	K050695	000
B2809808HO0010T6	K050695	000
B2809808HO0010X5	K050695	000
B2809808HO0010X6	K050695	000
B2809808HO0012T5	K050695	000
B2809808HO0012T6	K050695	000
B2809808HO0012X5	K050695	000
B2809808HO0012X6	K050695	000
B2809809HO0004T5	K050695	000
B2809861PH2424X5	K050695	000
B280809HO0010CX609	K050695	000
B280809HO0010X60	K050695	000
B280810UV0016X6I0	K050695	000
B280810UV0024T6I0	K050695	000
B280810UV1200T6I0	K050695	000
B280810UV1200X6I0	K050695	000
B280810UV1212T6I0	K050695	000
B280810UV1600T6I0	K050695	000
B280810UV2400T6I0	K050695	000
B280810UV2400X6I0	K050695	000
B280810UV2800T6I0	K050695	000
B280810UV2800X6I0	K050695	000
B280811UV0012T6E0	K050695	000
B280810UV0016T6I0	K050695	000
B280810UV0012X6I0	K050695	000
B280809HO0012T60	K050695	000
B280809HO0012X60	K050695	000
B280809HO0600T60	K050695	000
B280809HO0600T6ND0	K050695	000
B280809HO0800T60	K050695	000
B280809HO0800X60	K050695	000
B280809HO1000T60	K050695	000
B280809HO1000X60	K050695	000
B280809HO1200T60	K050695	000
B280809HO1200X60	K050695	000
B280810UV0012T6I0	K050695	000
B280811UV0012T6I0	K050695	000
B280811UV0012X6I0	K050695	000
B280811UV0016T6E0	K050695	000
B280811UV1212X6E0	K050695	000
B280811UV1212X6I0	K050695	000
B280811UV1414T6E0	K050695	000
B280811UV1414X6E0	K050695	000
B280811UV1600X6I0	K050695	000
B280811UV2400X6E0	K050695	000
B280861PH0024X60	K050695	000
B280861PH0048X60	K050695	000
B280861PH1236X60	K050695	000
B280861PH2424X60	K050695	000
B280861PH3612X60	K050695	000
B280811UV1212T6I0	K050695	000
B280811UV1212T6E0	K050695	000
B280811UV0016T6I0	K050695	000
B280811UV0016X6E0	K050695	000
B280811UV0016X6I0	K050695	000
B280811UV0024T6E0	K050695	000
B280811UV0024T6I0	K050695	000
B280811UV0024X6E0	K050695	000
B280811UV0024X6I0	K050695	000
B280811UV0028T6E0	K050695	000
B280811UV0028T6I0	K050695	000
B280811UV0028X6E0	K050695	000
B280811UV0028X6I0	K050695	000
B280861PH4800X60	K050695	000
B280809HO1000CT605	K050695	000
B280801MI0604X60	K050695	000
B280801MI1000T60	K050695	000
B280801MI1000X60	K050695	000
B280802MI0010T60	K050695	000
B280802MI0010X60	K050695	000
B280802MI0406T60	K050695	000
B280802MI0604T60	K050695	000
B280802MI0604X60	K050695	000
B280802MI1000T60	K050695	000
B280802MI1000X60	K050695	000
B280803MI0010T60	K050695	000
B280801MI0604T60	K050695	000
B280801MI0406X60	K050695	000
B280810UV2400CX6E0	K050695	000
B280811UV0012CX6E0	K050695	000
B280811UV0016CX6E0	K050695	000
B280811UV0024CX5E0	K050695	000
B280811UV0024CX6E0	K050695	000
B280811UV0028CX6E02	K050695	000
B280811UV1600CX6E0	K050695	000
B280800MI0010T60	K050695	000
B280800MI0010X60	K050695	000
B280801MI0010T60	K050695	000
B280801MI0010X60	K050695	000
B280803MI0010X60	K050695	000
B280803MI0604T60	K050695	000
B280803MI0604X60	K050695	000
B280808HO0012T60	K050695	000
B280808HO0012X60	K050695	000
B280809HO0004T60	K050695	000
B280809HO0004T6ND0	K050695	000
B280809HO0004X60	K050695	000
B280809HO0004X6ND0	K050695	000
B280809HO0006T60	K050695	000
B280809HO0006T6ND0	K050695	000
B280809HO0006X60	K050695	000
B280809HO0008T60	K050695	000
B280809HO0008X60	K050695	000
B280808HO0010X60	K050695	000
B280808HO0010T60	K050695	000
B280808HO0004T60	K050695	000
B280808HO0004T6ND0	K050695	000
B280808HO0004T6ND220	K050695	000
B280808HO0004X60	K050695	000
B280808HO0004X6ND0	K050695	000
B280808HO0006T60	K050695	000
B280808HO0006T6ND0	K050695	000
B280808HO0006X60	K050695	000
B280808HO0006X6ND0	K050695	000
B280808HO0008T60	K050695	000
B280808HO0008X60	K050695	000
B280809HO0010T60	K050695	000