FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
Lumenis Stellar M22
K Number: DEN200028
·
Decision Feb 23, 2021
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
28
Review Days
309
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Basic Information
- Device Name
- Lumenis Stellar M22
- K Number
- DEN200028
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 886.5201
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Applicant
- Lumenis, Ltd.
- Date Received
- April 20, 2020
- Decision Date
- February 23, 2021
- Product Code
- QIU
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIU | Intense Pulsed Light Device For Managing Dry Eye | FDA class 2 | Ophthalmic |
Other Clearances by Lumenis, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | Oct 19, 2021 | Substantially Equivalent |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | Dec 24, 2020 | Substantially Equivalent |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Oct 22, 2020 | Substantially Equivalent |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Jul 16, 2020 | Substantially Equivalent |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Jan 16, 2020 | Substantially Equivalent |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Apr 3, 2018 | Substantially Equivalent |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Sep 18, 2017 | Substantially Equivalent |
| K170060 | M22 and ResurFx Systems | Aug 9, 2017 | Substantially Equivalent |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | May 22, 2017 | Substantially Equivalent |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System | Feb 28, 2017 | Substantially Equivalent |