FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LightLas Pattern Scanning System - TruScan Pro
K Number: K190448
·
Decision May 24, 2019
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
176
Applicant Total
1
Review Days
88
Basic Information
- Device Name
- LightLas Pattern Scanning System - TruScan Pro
- K Number
- K190448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Light-Med(USA), INC.
- Date Received
- February 25, 2019
- Decision Date
- May 24, 2019
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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