The following data is part of a premarket notification filed by Altus Medical, Inc. with the FDA for Family Of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, Ii And Future Models.
| Device ID | K014040 |
| 510k Number | K014040 |
| Device Name: | FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALTUS MEDICAL, INC. 821 COWAN RD. Burlingame, CA 94010 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor ALTUS MEDICAL, INC. 821 COWAN RD. Burlingame, CA 94010 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-07 |
| Decision Date | 2002-06-03 |
| Summary: | summary |