FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
K Number: K112013
·
Decision Jan 13, 2012
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
28
Review Days
183
Basic Information
- Device Name
- EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
- K Number
- K112013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOLITEC, INC.
- Date Received
- July 14, 2011
- Decision Date
- January 13, 2012
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by BIOLITEC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K112253 | CERALAS 147NM DIODE LASER SYSTEM | Sep 20, 2011 | Substantially Equivalent |
| K110080 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | Feb 24, 2011 | Substantially Equivalent |
| K102755 | CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER | Dec 16, 2010 | Substantially Equivalent |
| K101712 | ENDOVASCULAR LAER VEIN SYSTEM KIT | Oct 27, 2010 | Substantially Equivalent |
| K100726 | CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM | Sep 15, 2010 | Substantially Equivalent |
| K090164 | CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER | Jun 26, 2009 | Substantially Equivalent |
| K083682 | 180W CERELAS D 980NM DIODE LASER, MODEL D180 | Jan 9, 2009 | Substantially Equivalent |
| K082225 | 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 | Dec 3, 2008 | Substantially Equivalent |
| K082263 | CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 | Oct 24, 2008 | Substantially Equivalent |
| K081015 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Jul 8, 2008 | Substantially Equivalent |