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Pulsaderm, LLC

3 FDA records filed under this company name, from 2017 to 2018, in hair growth (OAP, 1), light for acne (OLP, 1), light for wrinkles (OHS, 1).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 1)

510(k) cleared

Hair Laser Headband

510(k) number
K182501
Applicant
Pulsaderm, LLC
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

LED and light devices for acne (OLP, 1)

510(k) cleared

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

510(k) number
K170111
Applicant
Pulsaderm, LLC
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

LED and light devices for wrinkles (OHS, 1)

510(k) cleared

Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

510(k) number
K163329
Applicant
Pulsaderm, LLC
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)