The following data is part of a premarket notification filed by Lightscalpel Llc with the FDA for Lightscalpel.
Device ID | K123037 |
510k Number | K123037 |
Device Name: | LIGHTSCALPEL |
Classification | Powered Laser Surgical Instrument |
Applicant | LIGHTSCALPEL LLC 16932 Woodinville Redmond Rd NE Ste 107 Woodinville, WA 98072 |
Contact | David Walters |
Correspondent | David Walters LIGHTSCALPEL LLC 16932 Woodinville Redmond Rd NE Ste 107 Woodinville, 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 | 2012-09-28 |
Decision Date | 2012-11-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851842007197 | K123037 | 000 |
00851842007180 | K123037 | 000 |
00851842007029 | K123037 | 000 |
00851842007623 | K123037 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() LIGHTSCALPEL 90237948 not registered Live/Pending |
LightScalpel, LLC 2020-10-06 |
![]() LIGHTSCALPEL 85005837 3889495 Live/Registered |
LightScalpel LLC 2010-04-04 |