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Silver Bay, LLC

3 FDA records filed under this company name, from 2010 to 2012, in light for wrinkles (OHS, 1), light for acne (OLP, 2).

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.

LED and light devices for wrinkles (OHS, 1)

510(k) clearedAug 14, 2012

C100 WRINKLE REDUCTION DEVICE

510(k) number: K112362
Applicant: Silver Bay, LLC
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Aug 17, 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 8.

FDA database record FDA document (PDF)

LED and light devices for acne (OLP, 2)

510(k) clearedJan 18, 2012

QUASAR CALYPSO

510(k) number: K111286
Applicant: Silver Bay, 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: May 6, 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 6.

FDA database record FDA document (PDF)

510(k) clearedAug 27, 2010

QUASAR BLUE LIGHT THERAPY SYSTEM

510(k) number: K093963
Applicant: Silver Bay, 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: Dec 23, 2009

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)