Reference Source

Lucky Beauty Equipment Co., LTD. · 89-08 · CHINA

For Lucky Beauty Equipment 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 LBS11 RF Skin Lift | Lbs56 Lipolaser | Panda B; RF Beauty | Lipolaser Machine | Lbs54 lipo Laser Fat Burning | Lbs12 Vertical RF | Panda B; RF Beauty | Lipolaser Machine | LBS11 RF Skin Lift | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | Lipolaser Machine | Lbs54 lipo Laser Fat Burning | Lbs12 Vertical RF | Lbs56 Lipolaser | LBS11 RF Skin Lift | Panda B; RF Beauty | LBS11 RF Skin Lift | Lbs54 lipo Laser Fat Burning | Lipolaser Machine | Lbs12 Vertical RF | Panda B; RF Beauty | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs56 Lipolaser | Lbs12 Vertical RF | Lbs12 Vertical RF | LBS11 RF Skin Lift | Panda B; RF Beauty | Lbs54 lipo Laser Fat Burning | Lbs56 Lipolaser | Lipolaser Machine; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 01/17/2014; address is Huaqiao Build Room , 1 Daqiao North Rd; Pukou , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm
Lucky Beauty Equipment 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
Huaqiao Build Room , 1 Daqiao North Rd; Pukou , Nanjing, Jiangsu CHINA verified
Date published
01/17/2014 verified
Product code
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
LBS11 RF Skin Lift | Lbs56 Lipolaser | Panda B; RF Beauty | Lipolaser Machine | Lbs54 lipo Laser Fat Burning | Lbs12 Vertical RF | Panda B; RF Beauty | Lipolaser Machine | LBS11 RF Skin Lift | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | Lipolaser Machine | Lbs54 lipo Laser Fat Burning | Lbs12 Vertical RF | Lbs56 Lipolaser | LBS11 RF Skin Lift | Panda B; RF Beauty | LBS11 RF Skin Lift | Lbs54 lipo Laser Fat Burning | Lipolaser Machine | Lbs12 Vertical RF | Panda B; RF Beauty | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs56 Lipolaser | Lbs12 Vertical RF | Lbs12 Vertical RF | LBS11 RF Skin Lift | Panda B; RF Beauty | Lbs54 lipo Laser Fat Burning | Lbs56 Lipolaser | Lipolaser Machine each item verified
FDA notes
Class II | Class II | Class II | Class II | Class II | class II | Class II | Class II | Class II | class II | Class II | Class II | Class II | Class II | class II | Class II | Class II | Class II | Class II | Class II | Class II | class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | class II | class II | 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

Lucky Beauty Equipment Co., LTD. Date Published : 01/17/2014 Huaqiao Build Room , 1 Daqiao North Rd; Pukou , Nanjing, Jiangsu CHINA 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 01/17/2014 Desc: LBS11 RF Skin Lift Notes: Class II 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 01/17/2014 Desc: Lbs56 Lipolaser Notes: Class II 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 01/17/2014 Desc: Panda B; RF Beauty Notes: Class II 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 01/17/2014 Desc: Lipolaser Machine Notes: Class II 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 01/17/2014 Desc: Lbs54 lipo Laser Fat Burning Notes: Class II 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 01/17/2014 Desc: Lbs12 Vertical RF Notes: class II 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: Panda B; RF Beauty Notes: Class II 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: Lipolaser Machine Notes: Class II 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: LBS11 RF Skin Lift Notes: Class II 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: Lbs12 Vertical RF Notes: class II 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: Lbs56 Lipolaser Notes: Class II 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: Lbs54 lipo Laser Fat Burning Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: Lipolaser Machine Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: Lbs54 lipo Laser Fat Burning Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: Lbs12 Vertical RF Notes: class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: Lbs56 Lipolaser Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: LBS11 RF Skin Lift Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: Panda B; RF Beauty Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: LBS11 RF Skin Lift Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: Lbs54 lipo Laser Fat Burning Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: Lipolaser Machine Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: Lbs12 Vertical RF Notes: class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: Panda B; RF Beauty Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: Lbs56 Lipolaser Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 01/17/2014 Desc: Lbs54 lipo Laser Fat Burning Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 01/17/2014 Desc: LBS11 RF Skin Lift Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 01/17/2014 Desc: Lipolaser Machine Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 01/17/2014 Desc: Panda B; RF Beauty Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 01/17/2014 Desc: Lbs56 Lipolaser Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 01/17/2014 Desc: Lbs12 Vertical RF Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2014 Desc: Lbs12 Vertical RF Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2014 Desc: LBS11 RF Skin Lift Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2014 Desc: Panda B; RF Beauty Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2014 Desc: Lbs54 lipo Laser Fat Burning Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2014 Desc: Lbs56 Lipolaser Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2014 Desc: Lipolaser Machine Notes: Class II

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

Source

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