illumiflow 148 Laser Cap
FDA 510(k) K173843 · Eglobal, LLC
510(k) numberK173843
Submission
- Device name
- illumiflow 148 Laser Cap
- Applicant
- Eglobal, LLC
Scottsdale, AZ, US - Received
- December 18, 2017
- Decision date
- January 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
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More from Shenzhen Kaiyan Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K162071 | IllumiFlow Laser CapOAP · Traditional | 02/24/2017SE |
Questions and answers
When was illumiflow 148 Laser Cap cleared by the FDA?
illumiflow 148 Laser Cap (K173843) received a 510(k) decision of Substantially Equivalent on January 26, 2018, 39 days after the submission was received.
What is the product code of K173843?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.