Reference Source

GUANGZHOU RUIMEI TECHNOLOGY CO. LTD. · 89-08 · CHINA

For GUANGZHOU RUIMEI TECHNOLOGY 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 Facial Beauty Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | Facial Beauty Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | Facial Beauty Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | Facial Beauty Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat; date published is 07/11/2011; address is Hengsheng Building B, Huanshi Room 1019 , No. 25 Zhong Road; Yuexiu District , Guangzhou, CHINA, verified against its source on 2026-09-16.

Firm
GUANGZHOU RUIMEI TECHNOLOGY 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
Hengsheng Building B, Huanshi Room 1019 , No. 25 Zhong Road; Yuexiu District , Guangzhou, CHINA verified
Date published
07/11/2011 verified
Product code
79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat each item verified
Product
Facial Beauty Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | Facial Beauty Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | Facial Beauty Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | Facial Beauty Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System each item verified
FDA notes
Class II, DWPE Date 4/5/2013 | Class II | Class II | Class II | Class II | Class II, DWPE Date 4/5/2013 | Class II | Class II | Class II | Class II | Class II | Class II | Class II, DWPE Date 4/5/2013 | Class II | Class II | Class II | Class II | Class II | Class II; 4/5/2013 | Class II | Class II | Class II | Class II | Class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

GUANGZHOU RUIMEI TECHNOLOGY CO. LTD. Date Published : 07/11/2011 Hengsheng Building B, Huanshi Room 1019 , No. 25 Zhong Road; Yuexiu District , Guangzhou, CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 04/05/2013 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 G - - FE Brush, Dermabrasion Date Published: 07/11/2011 Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II 79 G - - FE Brush, Dermabrasion Date Published: 07/11/2011 Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II 79 G - - FE Brush, Dermabrasion Date Published: 07/11/2011 Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II 79 G - - FE Brush, Dermabrasion Date Published: 07/11/2011 Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II 79 G - - FE Brush, Dermabrasion Date Published: 04/05/2013 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 G - - FE Brush, Dermabrasion Date Published: 07/11/2011 Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 07/11/2011 Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 07/11/2011 Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 07/11/2011 Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 07/11/2011 Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 07/11/2011 Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 01/23/2019 Desc: Facial Beauty Machine Notes: Class II; 4/5/2013 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/11/2011 Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/11/2011 Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/11/2011 Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/11/2011 Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/11/2011 Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II

— accessdata.fda.gov, retrieved 2026-09-15

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