F65 Laser System
FDA 510(k) K222790 · Lumenis Be, Ltd.
510(k) numberK222790
Submission
- Device name
- F65 Laser System
- Applicant
- Lumenis Be, Ltd.
Yokneam, IL - Received
- September 15, 2022
- Decision date
- June 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was F65 Laser System cleared by the FDA?
F65 Laser System (K222790) received a 510(k) decision of Substantially Equivalent on June 14, 2023, 272 days after the submission was received.
What is the product code of K222790?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.