FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
R:GEN Laser System
K Number: K153769
·
Decision Oct 5, 2016
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
29
Review Days
280
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Basic Information
- Device Name
- R:GEN Laser System
- K Number
- K153769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lutronic Corporation
- Date Received
- December 30, 2015
- Decision Date
- October 5, 2016
- 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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