The following data is part of a premarket notification filed by Scarlet Rf, Inc with the FDA for Hyperion Long Pulsed Nd: Yag Laser.
| Device ID | K132286 |
| 510k Number | K132286 |
| Device Name: | HYPERION LONG PULSED ND: YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SCARLET RF, INC 28 STAFFORD DRIVE West Windsor, NJ 08550 |
| Contact | Kevin J Choi |
| Correspondent | Kevin J Choi SCARLET RF, INC 28 STAFFORD DRIVE West Windsor, NJ 08550 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-23 |
| Decision Date | 2014-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035500511 | K132286 | 000 |
| 08800035500504 | K132286 | 000 |
| 08800035500429 | K132286 | 000 |
| 08800035500436 | K132286 | 000 |
| 08800035500443 | K132286 | 000 |
| 08800035500450 | K132286 | 000 |
| 08800035500467 | K132286 | 000 |
| 08800035500474 | K132286 | 000 |
| 08800035500481 | K132286 | 000 |
| 08800035500306 | K132286 | 000 |