Lucky Beauty Equipment Co., LTD. · 89-08 · CHINA
For Lucky Beauty Equipment 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 Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lipolaser Machine | LBS11 RF Skin Lift | Lbs54 lipo Laser Fat Burning | Lbs56 Lipolaser | Lbs12 Vertical RF; 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 2026-09-30.
- 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
- Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lbs12 Vertical RF | Lbs56 Lipolaser | Lbs54 lipo Laser Fat Burning | LBS11 RF Skin Lift | Lipolaser Machine | Panda B; RF Beauty | Lipolaser Machine | LBS11 RF Skin Lift | Lbs54 lipo Laser Fat Burning | Lbs56 Lipolaser | Lbs12 Vertical RF 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
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
— 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 - - 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: Lbs12 Vertical RF 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: Lbs54 lipo Laser Fat Burning Notes: Class II 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: Lipolaser Machine 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: 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 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: Lipolaser Machine Notes: Class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/17/2014 Desc: Panda B; RF Beauty 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: Lbs54 lipo Laser Fat Burning 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: Lipolaser Machine 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: Lbs12 Vertical RF Notes: class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/17/2014 Desc: Lbs56 Lipolaser 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: LBS11 RF Skin Lift Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating 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: Lbs12 Vertical RF 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: 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 - - 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: Lipolaser Machine 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: 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: Lbs12 Vertical RF Notes: class II
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html