Micromode Medical Ltd · 89-08 · UNITED KINGDOM
For Micromode Medical Ltd · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; 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 9 Spring Villa Park Spring Villa , Edgware, UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- Micromode Medical 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
- UNITED KINGDOM verified
- Address
- 9 Spring Villa Park Spring Villa , Edgware, 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
What the source says
Micromode Medical Ltd Date Published : 07/19/2011 9 Spring Villa Park Spring Villa , Edgware, UNITED KINGDOM 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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