ALEX TA2 ERASER
FDA 510(k) clearance K980131 · decided 1998-02-17
Clearance details
- K-number
- K980131
- Device name
- ALEX TA2 ERASER
- Applicant
- Light Age, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-15
- Decision date
- 1998-02-17
- Days to decision
- 33 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
- Somerset, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.