| Device Classification Name |
Light Based Over-The-Counter Hair Removal
|
|---|
| 510(k) Number |
K233887 |
|---|
| Device Name |
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) |
|---|
| Applicant |
| Shenzhen Ulike Smart Electronics Co., Ltd. |
| 810, Bldg. 1, Xunmei Science And Technology Plaza, # 8 |
| Keyuan Rd., Science Park Community, Yuehai Sub-District |
|
Shenzhen,
CN
518000
|
|
| Applicant Contact |
Blue Fang |
| Correspondent |
| Shenzhen Ulike Smart Electronics Co., Ltd. |
| 810, Bldg. 1, Xunmei Science And Technology Plaza, # 8 |
| Keyuan Rd., Science Park Community, Yuehai Sub-District |
|
Shenzhen,
CN
518000
|
|
| Correspondent Contact |
Blue Fang |
| Regulation Number | 878.4810 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/08/2023 |
|---|
| Decision Date | 01/22/2024 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Statement |
Statement
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
