CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.
FDA 510(k) clearance K052647 · decided 2005-11-09
Clearance details
- K-number
- K052647
- Device name
- CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.
- Applicant
- American Spine Center, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-26
- Decision date
- 2005-11-09
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Belleville, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.