GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
FDA 510(k) clearance K171707 · decided 2017-08-08
Clearance details
- K-number
- K171707
- Device name
- GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
- Applicant
- Gowoonsesang Cosmetics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-08
- Decision date
- 2017-08-08
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gowoonsesang Cosmetics Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.