The following data is part of a premarket notification filed by Microlight Corporation Of America with the FDA for Microlight 830 Laser System.
| Device ID | K010175 |
| 510k Number | K010175 |
| Device Name: | MICROLIGHT 830 LASER SYSTEM |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | MICROLIGHT CORPORATION OF AMERICA 2935 HIGHLAND LAKES Missouri City, TX 77459 |
| Contact | Michael Barbour |
| Correspondent | Michael Barbour MICROLIGHT CORPORATION OF AMERICA 2935 HIGHLAND LAKES Missouri City, TX 77459 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-18 |
| Decision Date | 2002-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859626006268 | K010175 | 000 |
| 00859626006251 | K010175 | 000 |
| 00859626006183 | K010175 | 000 |
| 00859626006176 | K010175 | 000 |
| 00859626006107 | K010175 | 000 |
| 00859626006046 | K010175 | 000 |
| 00859626006008 | K010175 | 000 |
| 00859626006343 | K010175 | 000 |