SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL
FDA 510(k) clearance K962109 · decided 1997-03-13
Clearance details
- K-number
- K962109
- Device name
- SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL
- Applicant
- Classy Lady by Mehl of Puerto Rico, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-31
- Decision date
- 1997-03-13
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Budd Lake, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.