Device Classification Name |
light based over-the-counter hair removal
|
510(k) Number |
K223524 |
Device Name |
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 |
Applicant |
MorLaser Shenzhen Co., Ltd. |
313, 314, 315 & 4th Floor, Building E, Tangtou No.1 |
Industry District, Shiyan Town, Bao’an District |
Shenzhen,
CN
518108
|
|
Applicant Contact |
Janny Shao |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
Rm 2401 Zhenye International Business Center, No. 3101-90 |
Qianhai Road |
Shenzhen,
CN
518052
|
|
Correspondent Contact |
Riley Chen |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/23/2022 |
Decision Date | 02/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|