Micromode Medical Ltd · 89-08 · UNITED KINGDOM
For Micromode Medical Ltd, 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 9 Spring Villa Park Spring Villa , Edgware, UNITED KINGDOM, verified against its source on 2026-09-30.
- 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
— 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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html