Cleared Special

K161849 - Bright

K161849 is an FDA 510(k) clearance for Bright, manufactured by Tanda Beauty Canada, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Special 510(k) pathway after a 24-day FDA review.

K161849 · Tanda Beauty Canada, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
24d
Days
Class 2
Risk

K161849 is an FDA 510(k) clearance for the Bright. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Tanda Beauty Canada, Inc. (Cambridge, CA). The FDA issued a Cleared decision on July 29, 2016 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161849

510(k) Number K161849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date July 29, 2016
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OHS Light Based Over The Counter Wrinkle Reduction

All 160
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K161849.
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
K163329 · Pulsaderm, LLC · Apr 2017
Silk'n HST
K162784 · Home Skinovations , Ltd. · Mar 2017
RED Light Device
K162489 · Zhongshan Bisen Plastic Electronic Products Co., Ltd. · Jan 2017
Perfectio LED infrared device
K152332 · Omm Imports Inc Dba Zero Gravity · Feb 2016
Strialite
K151337 · Centre Light Solutions, LLC · Feb 2016
LightStim Professional 2-Panel Light
K151336 · Led Intellectual Properties, LLC · Oct 2015