Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
FDA 510(k) clearance K240874 · decided 2024-05-28
Clearance details
- K-number
- K240874
- Device name
- Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
- Applicant
- Theralaser Medtech (China) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-29
- Decision date
- 2024-05-28
- Days to decision
- 60 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
- Ingxiang High-Tech Industrial Park Chang, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Theralaser Medtech (China) Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.