FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
K Number: K202241
·
Decision Jul 2, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
10
Applicant Total
4
Review Days
326
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Basic Information
- Device Name
- LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
- K Number
- K202241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6200
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hamilton Thorne, Inc.
- Date Received
- August 10, 2020
- Decision Date
- July 2, 2021
- Product Code
- MRX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MRX | System, Assisted Reproduction Laser | FDA class 2 | Obstetrics/Gynecology |
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