AKLARUS PHOTOTHERAPY SYSTEM
FDA 510(k) clearance K083183 · decided 2009-07-16
Clearance details
- K-number
- K083183
- Device name
- AKLARUS PHOTOTHERAPY SYSTEM
- Applicant
- Hill Laboratories Co.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-28
- Decision date
- 2009-07-16
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Frazer, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.