MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
FDA 510(k) clearance K991628 · decided 1999-08-09
Clearance details
- K-number
- K991628
- Device name
- MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
- Applicant
- Esc Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-11
- Decision date
- 1999-08-09
- Days to decision
- 90 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
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.