Reference Source

CACI International · 89-08 · UNITED KINGDOM

For CACI International, import alert is 89-08; country is UNITED KINGDOM; 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 code is 79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 97 R - - AL Massager, Ultrasonic Non-Medical Devices; date published is 07/19/2011; address is C a C I House , Unit 9 Spring Villa Park , Edgware, Middlesex UNITED KINGDOM, verified against its source on 2026-09-30.

Firm
CACI International 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
UNITED KINGDOM verified
Address
C a C I House , Unit 9 Spring Villa Park , Edgware, Middlesex UNITED KINGDOM verified
Date published
07/19/2011 verified
Product code
79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 97 R - - AL Massager, Ultrasonic Non-Medical Devices each item verified
FDA notes
Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III | Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III | Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III | Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III 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

CACI International Date Published : 07/19/2011 C a C I House , Unit 9 Spring Villa Park , Edgware, Middlesex UNITED KINGDOM

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

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 and FDA notes

79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III 89 I - - SA Massager, Therapeutic, Electric Date Published: 07/19/2011 Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/19/2011 Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III 97 R - - AL Massager, Ultrasonic Non-Medical Devices Date Published: 07/19/2011 Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

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

Source

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