Braun Aura 7 (6041)
Device Facts
| Record ID | K261975 |
|---|---|
| Device Name | Braun Aura 7 (6041) |
| Applicant | CyDen Limited |
| Product Code | OHT · General, Plastic Surgery |
| Decision Date | Sep 30, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Braun Aura 7 is intended for the removal of unwanted hair. The Braun Aura 7 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.
Device Story
Braun Aura 7 (6041) is an over-the-counter, mains-powered Intense Pulsed Light (IPL) device for home hair removal. Device consists of a handset, hardwired base unit, and AC power cord. Operation involves AC-to-DC conversion to charge an electrical storage capacitor, which powers a flash lamp to emit optical energy. Light energy is absorbed by melanin in the hair shaft and converted to heat below the skin surface to inhibit hair regrowth. User operates device at home. Includes an 'Autoflash' firing mode. Device provides aesthetic hair removal benefits through repeated treatment regimes.
Clinical Evidence
Bench testing only. Device demonstrated compliance with AAMI/IEC 60601-1, IEC 60601-1-6, IEC 60601-2-83, IEC 60601-1-2, and IEC 62471. Biocompatibility testing performed per ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Technological Characteristics
Mains-powered IPL device. Components: handset, base unit, AC/DC converter, electrical storage capacitor, flash lamp. Standards: AAMI/IEC 60601-1 (electrical safety), IEC 60601-1-6 (usability), IEC 60601-2-83 (home light therapy), IEC 60601-1-2 (EMC), IEC 62471 (photobiological safety). Biocompatibility: ISO 10993-1, -5, -10. Features: Autoflash firing mode.
Indications for Use
Indicated for removal of unwanted hair and permanent reduction in hair regrowth in home-use settings.
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Predicate Devices
- SmoothSkin Pure Switch (SSC1) (K243362)
- iPulse SmoothSkin Gold Hair Removal System (k143003)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
September 30, 2026
CyDen Limited
Matthew Silverberg
Regulatory Engineer
Block A, Bay Studios Business Park, Fabian Way
Swansea, SA1 8QB
United Kingdom
Re: K261975
Trade/Device Name: Braun Aura 7 (6041)
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OHT
Dated: September 16, 2026
Received: September 16, 2026
Dear Matthew Silverberg:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261975 - Matthew Silverberg
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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K261975 - Matthew Silverberg
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(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2026.09.30
19:50:41 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261975 | ? |
| Please provide the device trade name(s). | | ? |
| Braun Aura 7 (6041) | | |
| Please provide your Indications for Use below. | | ? |
| The Braun Aura 7 is intended for the removal of unwanted hair. The Braun Aura 7 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. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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510(k) #: K261975
# 510(k) Summary
Prepared on: 2026-09-16
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | CyDen Limited |
| --- | --- |
| Applicant Address | Block A, Bay Studios Business Park, Fabian Way, SA1 8QB Swansea United Kingdom |
| Applicant Contact Telephone | +44 1792 274009 |
| Applicant Contact | Mr. Matthew Silverberg |
| Applicant Contact Email | msilverberg@cyden.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Braun Aura 7 (6041) |
| --- | --- |
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification Name | Light Based Over-The-Counter Hair Removal |
| Regulation Number | 878.4810 |
| Product Code(s) | OHT, N/A |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K243362 | SmoothSkin Pure Switch (SSC1) | OHT |
| k143003 | iPulse SmoothSkin Gold Hair Removal System | OHT,ONX,GE |
Device Description Summary
21 CFR 807.92(a)(4)
The 6041 device is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use.
The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp.
Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Braun Aura 7 is intended for the removal of unwanted hair. The Braun Aura 7 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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
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Same indications for use.
# Technological Comparison
21 CFR 807.92(a)(6)
The 6041 device has the same following characteristics.
- The same intended use.
- Operates with the same mode of actions.
- Has the same technological characteristics.
- Has the same shelf-life.
- Is manufactured and packed in the same manner.
- Has similar output parameters to the predicate device.
- Has the same safety features.
The following modification have been made to the SSC1 device.
- Aesthetic changes.
- Addition of the Autoflash firing mode.
# Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The device is compliant with the following Electrical Safety and Electromagnetic Compatibility standards.
1) AAMI / IEC 60601-1 : 2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
2) IEC 60601-1-6 : 2010 +AMD1:2013 +AMD2:2020 Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
3) IEC 60601-2-83 : 2019 +AMD1:2022 Medical Electrical Equipment: Part 2-83: Particular requirement for the basic safety and essential performance of home light therapy equipment
4) IEC 60601-1-2 : 2014+A1:2021 Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
5) IEC 62471: 2006 Photobiological safety of lamps and lamp systems
The device is compliant with the following Biocompatibility standards
1) ISO 10993-1 : 2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
2) ISO 10993-5 : 2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
3) ISO 10993-10 : 2010, Biological evaluation of medical devices Part 10: Tests for skin sensitization
The Braun Aura 7 (6041) has the same intended use, mode of action and similar operational characteristics as the predicate device. Therefore the Braun Aura 7 (6041) is found substantially equivalent to its predicate devices.
