Reference Source

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

For GUANGZHOU RUIMEI TECHNOLOGY CO. LTD., import alert is 89-08; country is CHINA; 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)"; product is Facial Beauty Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | Facial Beauty 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-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | Facial Beauty Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion 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-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 | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine; 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 2026-09-30.

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-08XLT; 4 IN 1 Diamond Dermabrasion System | Facial Beauty 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-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine | SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine | SYL-08XLT; 4 IN 1 Diamond Dermabrasion System | Facial Beauty Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion 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-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 | SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine | SYL-60 (NV-60); Diamond Dermabrasion Machine each item verified
FDA notes
Class II, DWPE Date 4/5/2013 | Class II | Class II, DWPE Date 4/5/2013 | Class II | 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 | 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

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

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-08XLT; 4 IN 1 Diamond Dermabrasion System 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-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: 07/11/2011 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-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: 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: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 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-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-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-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II 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-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-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-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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