The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Acupulse 30 And 40 Carbon Dioxide Laser System.
| Device ID | K082809 |
| 510k Number | K082809 |
| Device Name: | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2008-12-18 |
| Summary: | summary |