The following data is part of a premarket notification filed by Light Scalpel Llc with the FDA for Light Scalpel.
| Device ID | K141658 |
| 510k Number | K141658 |
| Device Name: | LIGHT SCALPEL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHT SCALPEL LLC 16932 WOODINIVILLE-REDMOND RD NE, SUITE 107 Woodiniville, WA 98072 |
| Contact | David Walters |
| Correspondent | David Walters LIGHT SCALPEL LLC 16932 WOODINIVILLE-REDMOND RD NE, SUITE 107 Woodiniville, WA 98072 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-20 |
| Decision Date | 2014-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851842007333 | K141658 | 000 |
| 00851842007104 | K141658 | 000 |
| 00851842007098 | K141658 | 000 |
| 00851842007081 | K141658 | 000 |
| 00851842007074 | K141658 | 000 |
| 00851842007067 | K141658 | 000 |
| 00851842007050 | K141658 | 000 |
| 00851842007043 | K141658 | 000 |
| 00851842007036 | K141658 | 000 |
| 00851842007111 | K141658 | 000 |
| 00851842007128 | K141658 | 000 |
| 00851842007326 | K141658 | 000 |
| 00851842007319 | K141658 | 000 |
| 00851842007302 | K141658 | 000 |
| 00851842007173 | K141658 | 000 |
| 00851842007166 | K141658 | 000 |
| 00851842007159 | K141658 | 000 |
| 00851842007142 | K141658 | 000 |
| 00851842007135 | K141658 | 000 |
| 00851842007005 | K141658 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LIGHT SCALPEL 74223103 not registered Dead/Abandoned |
Cogent Light Technologies, Inc. 1991-11-19 |