The following data is part of a premarket notification filed by Regulatory Technology Services, Llc with the FDA for Sol Portable Diode Laser Unit (with Wireless Foot Control).
| Device ID | K141838 |
| 510k Number | K141838 |
| Device Name: | SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Contact | Mark Job |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-07-08 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813LR1045CCD0 | K141838 | 000 |
| D813LR100060 | K141838 | 000 |
| D813LR10006CCD0 | K141838 | 000 |
| D813LR1001DW0 | K141838 | 000 |
| D813LR1001L0 | K141838 | 000 |
| D813LR1001W0 | K141838 | 000 |
| D813LR1001WCCD0 | K141838 | 000 |
| D813LR1001WCCDEMO0 | K141838 | 000 |
| D813LR1001WL0 | K141838 | 000 |
| D813LR10040 | K141838 | 000 |
| D813LR10101 | K141838 | 000 |
| D813LR1010CCD1 | K141838 | 000 |
| D813LR1012CCD1 | K141838 | 000 |
| D813LR10450 | K141838 | 000 |
| D81303398002801 | K141838 | 000 |