LT-300 HD
FDA 510(k) K160380 · Lutech Industries, Inc.
510(k) numberK160380
Submission
- Device name
- LT-300 HD
- Applicant
- Lutech Industries, Inc.
Ronkonkoma, NY, US - Received
- February 10, 2016
- Decision date
- May 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEX – Colposcope (And Colpomicroscope)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1630
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233043 | Smart Scope® CXHEX · Traditional | Periwinkle Technologies Pvt., Ltd. | 06/14/2024SE |
| K190187 | Gynescope SystemHEX · Traditional | Illumigyn , Ltd. | 05/08/2019SE |
| K182764 | Biop Digital ColposcopeHEX · Traditional | Biop Medical , Ltd. | 11/27/2018SE |
| K181034 | Pocket Colposcope SystemHEX · Traditional | Hadleigh Health Technologies, LLC | 09/21/2018SE |
| K170446 | LT-300 SD Digital Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 05/21/2017SE |
| K161871 | EVA (Enhanced Visual Assessment) SystemHEX · Traditional | Mobileodt , Ltd. | 12/19/2016SE |
| K160341 | Colposcope SystemHEX · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 09/14/2016SE |
| K151878 | Video ColposcopeHEX · Traditional | Edan Instruments, Inc. | 12/01/2015SE |
| K143119 | LT-300 Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 12/18/2014SE |
| K140754 | Cooper Surgical Leisegang Colposcope SystemHEX · Traditional | CooperSurgical, Inc. | 10/23/2014SE |
More from CooperSurgical, Inc.
Questions and answers
When was LT-300 HD cleared by the FDA?
LT-300 HD (K160380) received a 510(k) decision of Substantially Equivalent on May 13, 2016, 93 days after the submission was received.
What is the product code of K160380?
The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.