# Lucky Beauty Equipment Co., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Huaqiao Build Room , 1 Daqiao North Rd; Pukou , Nanjing, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 01/17/2014 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).