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Home Skinovations , Ltd.

7 FDA records filed under this company name, from 2010 to 2017, in hair removal (OHT, 4), light for wrinkles (OHS, 2), light for acne (OLP, 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 IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT, 4)

510(k) clearedAug 11, 2017

Silk'n Infinity

510(k) number: K171433
Applicant: Home Skinovations , Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 15, 2017

Indications for use

Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedOct 17, 2014

GLIDE DEVICE

510(k) number: K141242
Applicant: Home Skinovations , Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 14, 2014

Indications for use

Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedAug 14, 2013

GLIDE DEVICE

510(k) number: K131870
Applicant: Home Skinovations , Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 24, 2013

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 record FDA document (PDF)

510(k) clearedNov 10, 2010

SILK'N FLASH N GO

510(k) number: K103184
Applicant: Home Skinovations , Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Oct 29, 2010

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 record FDA document (PDF)

LED and light devices for wrinkles (OHS, 2)

510(k) clearedMar 25, 2017

Silk'n HST

510(k) number: K162784
Applicant: Home Skinovations , Ltd.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Oct 3, 2016

Indications for use, as filed

“The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedAug 19, 2011

SILK'N FX

510(k) number: K110301
Applicant: Home Skinovations , Ltd.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 2, 2011

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.

FDA database record FDA document (PDF)

LED and light devices for acne (OLP, 1)

510(k) clearedFeb 22, 2013

SILKN BLUE

510(k) number: K121435
Applicant: Home Skinovations , Ltd.
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: May 14, 2012

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.

FDA database record FDA document (PDF)