FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDELA UPC LASER PHOTOCOAGULATOR
K Number: K893630
·
Decision Aug 2, 1989
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
43
Review Days
83
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Basic Information
- Device Name
- CANDELA UPC LASER PHOTOCOAGULATOR
- K Number
- K893630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Candela Laser Corp.
- Date Received
- May 11, 1989
- Decision Date
- August 2, 1989
- 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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