Foreo AB

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Device Description : The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

Device Class : 2

Duns Number: 352394143

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Device Description : ISSA™ mini is a powered toothbrush that helps parents to monitor that their chil ISSA™ mini is a powered toothbrush that helps parents to monitor that their children are brushing their teeth twice a day. Featuring parental controls, the sad face ('Glum') will appear if teeth haven't been brushed in over 12 hours. The happy face ('Glee') will appear when teeth have been brushed for 2 minutes. With 2 speed settings, you can ensure your child is cleaning their teeth effectively. The ISSA™ mini is suitable for children ages 5+.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Device Description : ISSA™ mini is a powered toothbrush that helps parents to monitor that their chil ISSA™ mini is a powered toothbrush that helps parents to monitor that their children are brushing their teeth twice a day. Featuring parental controls, the sad face ('Glum') will appear if teeth haven't been brushed in over 12 hours. The happy face ('Glee') will appear when teeth have been brushed for 2 minutes. With 2 speed settings, you can ensure your child is cleaning their teeth effectively. The ISSA™ mini is suitable for children ages 5+.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and prom ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and promotes excellent oral hygiene. The silicone and polymer cross-design is the hygienic choice, offering the highest level of clean with bristles that harbor less bacteria than conventional nylon.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and prom ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and promotes excellent oral hygiene. The silicone and polymer cross-design is the hygienic choice, offering the highest level of clean with bristles that harbor less bacteria than conventional nylon.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and prom ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and promotes excellent oral hygiene. The silicone and polymer cross-design is the hygienic choice, offering the highest level of clean with bristles that harbor less bacteria than conventional nylon.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and prom ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and promotes excellent oral hygiene. The silicone and polymer cross-design is the hygienic choice, offering the highest level of clean with bristles that harbor less bacteria than conventional nylon.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Device Description : ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbr ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbrush. In addition to the brush head made 100% out of super-soft, ultra-hygienic silicone, the cleanest, softest toothbrush also has a smaller brush head fit for young brushers or adults who prefer a smaller brush surface and was created for those with sensitive gums. Brighten, whiten and polish without damaging the tooth enamel or irritating the gum tissue and enjoy your feather-soft brush head for up to a full year of smiles.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Device Description : ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbr ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbrush. In addition to the brush head made 100% out of super-soft, ultra-hygienic silicone, the cleanest, softest toothbrush also has a smaller brush head fit for young brushers or adults who prefer a smaller brush surface and was created for those with sensitive gums. Brighten, whiten and polish without damaging the tooth enamel or irritating the gum tissue and enjoy your feather-soft brush head for up to a full year of smiles.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Device Description : ISSA™ 2 Sensitive Set is an oral care solution for sensitive brushers that blend ISSA™ 2 Sensitive Set is an oral care solution for sensitive brushers that blends gentle brushing with enhanced technology.

Device Class : 1

Duns Number: 352394143

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1