510(k) DEN200028
- Device
- Lumenis Stellar M22
- Applicant
- Lumenis, Ltd.
- 510(k) number
- DEN200028
- Product code
- QIU
- Decision
- Unknown (DENG)
- Decision date
- 2021-02-23
- Date received
- 2020-04-20
- Regulation
- 886.5201
- Classification name
- Intense Pulsed Light Device For Managing Dry Eye
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shlomit Segman
- Address
- 6 Hakidma St. P.O. Box 240 Yokneam IL 2069204 2069204
FDA Registration Numbers#
- 2953684
- 3009040934
- 3021349626
Source Documents#
510(k) summary PDF not indicated by FDA