Aurolase Therapy, Laser Delivery Device (LDD)
FDA 510(k) clearance K202953 · decided 2022-10-03
Clearance details
- K-number
- K202953
- Device name
- Aurolase Therapy, Laser Delivery Device (LDD)
- Applicant
- Nanospectra Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-30
- Decision date
- 2022-10-03
- Days to decision
- 733 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
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.