Cleared Traditional

K171707 - GA-B

K171707 is an FDA 510(k) clearance for GA-B, manufactured by Gowoonsesang Cosmetics Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K171707 · Gowoonsesang Cosmetics Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
61d
Days
Class 2
Risk

K171707 is an FDA 510(k) clearance for the GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Gowoonsesang Cosmetics Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on August 8, 2017 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gowoonsesang Cosmetics Co., Ltd. devices

FDA 510(k) Submission Details - K171707

510(k) Number K171707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2017
Decision Date August 08, 2017
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1303
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K171707.
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
K172671 · Conmed Corporation · Oct 2017
TempSure
K171262 · Cynosure, Inc. · Sep 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · Stryker Instruments · Aug 2017
AUTOCON III 400
K171717 · KARL STORZ Endoscopy-America, Inc. · Aug 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K171066 · Covidien, LLC · Jun 2017
PK AIM
K170908 · Gyrus Acmi, Inc. · May 2017