Mychway Co. Ltd. · 89-08 · CHINA
For Mychway Co. Ltd. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device; product code is 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - RK Laser assisted lipolysis | 89 I - - SA Massager, Therapeutic, Electric; date published is 05/05/2013; address is Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA, verified against its source on 2026-09-16.
- Firm
- Mychway Co. Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA verified
- Date published
- 05/05/2013 verified
- Product code
- 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - RK Laser assisted lipolysis | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device each item verified
- FDA notes
- class II | class II | class II | Class II | class II each item verified
What the source says
Mychway Co. Ltd. Date Published : 05/05/2013 Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA 79 G - - FE Brush, Dermabrasion Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Laser Lipolysis Device Notes: class II 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II 79 O - - RK Laser assisted lipolysis Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html