OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004— 510(k) K040664
Substantially EquivalentOmnilight, Inc.
FDA 510(k) clearance K040664 for OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004, Substantially Equivalent on 2004-05-28. Applicant: Omnilight, Inc.. Device class: 2.
Clearance details
- Applicant
- Omnilight, Inc.
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Placitas,, NM, US
Recent devices under product code ILY
view all- K253965 — CureLight Medical Diode Laser Systems (CureLight F2-A15 +5 more
- K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
- K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- K223642 — LED Lip Perfector, model: ZC-05
- K221189 — OLIZ LTB-1000A
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.