The following data is part of a premarket notification filed by Coolanalgesia Ltd. with the FDA for Coolan 300.
| Device ID | K030810 |
| 510k Number | K030810 |
| Device Name: | COOLAN 300 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOLANALGESIA LTD. WILLIAM GATES BUILDING 15 J.J. THOMSON AVENUE Cambridge, England, GB Cb3 0fd |
| Contact | Peter Wilkinson |
| Correspondent | Pamela Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2004-05-05 |