ACU-GUARD
Powered Laser Surgical Instrument
ACUDERM, INC.
The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-guard.
Pre-market Notification Details
| Device ID | K915000 |
| 510k Number | K915000 |
| Device Name: | ACU-GUARD |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Contact | Charles R Yeh |
| Correspondent | Charles R Yeh ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-07 |
| Decision Date | 1992-01-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814105020873 | K915000 | 000 |
| 10814105020866 | K915000 | 000 |
| 10814105020859 | K915000 | 000 |
| 00814105020876 | K915000 | 000 |
| 00814105020869 | K915000 | 000 |
| 00814105020852 | K915000 | 000 |
Trademark Results [ACU-GUARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACU-GUARD 74420815 1831241 Live/Registered |
Acuderm Inc. 1993-08-05 |
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