CUTERA TABLETOP AESTHETIC PRODUCT
FDA 510(k) clearance K042165 · decided 2004-10-18
Clearance details
- K-number
- K042165
- Device name
- CUTERA TABLETOP AESTHETIC PRODUCT
- Applicant
- Cutera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-11
- Decision date
- 2004-10-18
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Brisbane, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane recall (Z-0329-2011) | Cutera Inc | 2010-11-09 |