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Cyden Limited

16 FDA records filed under this company name, from 2012 to 2026, in hair removal (OHT, 16).

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, 16)

510(k) clearedSep 25, 2026

Braun Aura 9 (6042)

510(k) number: K261977
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 12, 2026

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 5.

FDA database record FDA document (PDF)

510(k) clearedNov 27, 2024

SmoothSkin Pure Switch (SSC1)

510(k) number: K243362
Applicant: Cyden Limited
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, 2024

Indications for use, as filed

“The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedMar 29, 2024

SmoothSkin Pure Unplugged (SSB3)

510(k) number: K240587
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Mar 1, 2024

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 4.

FDA database record FDA document (PDF)

510(k) clearedDec 20, 2023

SmoothSkin Pure Adapt (SSG3)

510(k) number: K233782
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Nov 27, 2023

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 4.

FDA database record FDA document (PDF)

510(k) clearedApr 27, 2023

Braun Skin i.expert

510(k) number: K230911
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Mar 31, 2023

Indications for use, as filed

“The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

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) clearedJan 26, 2022

SmoothSkin Pure Mini

510(k) number: K213692
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Nov 23, 2021

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) clearedJul 28, 2021

Braun Silk.expert Mini

510(k) number: K211994
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 28, 2021

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) clearedFeb 21, 2020

SmoothSkin Pure

510(k) number: K200184
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jan 24, 2020

Indications for use

Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.

FDA database record FDA document (PDF)

510(k) clearedSep 24, 2019

SmoothSkin BARE+

510(k) number: K192010
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jul 29, 2019

Indications for use, as filed

“The SmoothSkin BARE+ Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin BARE+ is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

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) clearedMar 18, 2019

BRAUN Silk.expert Pro 5

510(k) number: K190354
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 15, 2019

Indications for use, as filed

“The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

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) clearedMar 18, 2019

BRAUN Silk Expert Pro 3

510(k) number: K190366
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 15, 2019

Indications for use, as filed

“The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

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) clearedMar 3, 2017

iPulse SmoothSkin BARE Hair Removal Device

510(k) number: K163552
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 19, 2016

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 16, 2016

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

510(k) number: K162231
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Aug 8, 2016

Indications for use, as filed

“The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

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) clearedApr 14, 2016

iPulse SmoothSkin Gold Hair Removal Device

510(k) number: K160968
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Apr 6, 2016

Indications for use, as filed

“The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

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) clearedJul 12, 2013

IPULSE HAIR REMOVAL SYSTEM

510(k) number: K130315
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 8, 2013

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 5.

FDA database record FDA document (PDF)

510(k) clearedOct 23, 2012

IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM

510(k) number: K122280
Applicant: Cyden Limited
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jul 30, 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)