STAR-LITE -LM, MODEL SL8809
FDA 510(k) clearance K092460 · decided 2010-03-05
Clearance details
- K-number
- K092460
- Device name
- STAR-LITE -LM, MODEL SL8809
- Applicant
- Ps Advanced Engineering
- Decision
- Substantially Equivalent
- Date received
- 2009-08-11
- Decision date
- 2010-03-05
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Alhambra, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ps Advanced Engineering
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.