The following data is part of a premarket notification filed by Zolar Technology & Mfg. Co. Inc. with the FDA for Photon Photon Plus.
| Device ID | K122020 |
| 510k Number | K122020 |
| Device Name: | PHOTON PHOTON PLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZOLAR TECHNOLOGY & MFG. CO. INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk ZOLAR TECHNOLOGY & MFG. CO. INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-10 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055817017 | K122020 | 000 |
| 00628055817000 | K122020 | 000 |