CANDELA RETINAL CAMERA— 510(k) K913314
Substantially EquivalentCandela Laser Corp.
FDA 510(k) clearance K913314 for CANDELA RETINAL CAMERA, Substantially Equivalent on 1992-01-23. Applicant: Candela Laser Corp.. Device class: 2.
Clearance details
- Applicant
- Candela Laser Corp.
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayland, MA, US
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