The following data is part of a premarket notification filed by Avant Wellness Systems, Llc with the FDA for Avant Laser.
| Device ID | K123474 |
| 510k Number | K123474 |
| Device Name: | AVANT LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | AVANT WELLNESS SYSTEMS, LLC 1020 CALLE CORDILLERA, STE 107 San Clemente, CA 92673 |
| Contact | Andy Hewitson |
| Correspondent | Andy Hewitson AVANT WELLNESS SYSTEMS, LLC 1020 CALLE CORDILLERA, STE 107 San Clemente, CA 92673 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852116008025 | K123474 | 000 |
| 00852116008018 | K123474 | 000 |
| 00852116008001 | K123474 | 000 |
| 00852116008087 | K123474 | 000 |
| 00852116008070 | K123474 | 000 |
| 00852116008063 | K123474 | 000 |
| 00852116008056 | K123474 | 000 |
| 00852116008049 | K123474 | 000 |
| 00852116008032 | K123474 | 000 |