FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLITE LASER SYSTEM
K Number: K952636
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
19
Review Days
53
Basic Information
- Device Name
- MEDLITE LASER SYSTEM
- K Number
- K952636
- 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
- CONTINUUM BIOMEDICAL, INC.
- Date Received
- June 8, 1995
- Decision Date
- July 31, 1995
- 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 CONTINUUM BIOMEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K992013 | DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER | Sep 8, 1999 | Substantially Equivalent |
| K983054 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER | Feb 10, 1999 | Substantially Equivalent |
| K973719 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER | Dec 23, 1997 | Substantially Equivalent |
| K970808 | MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER | Sep 5, 1997 | Substantially Equivalent |
| K971903 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER | Aug 21, 1997 | Substantially Equivalent |
| K971879 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER | Aug 14, 1997 | Substantially Equivalent |
| K970934 | CB ERBIUM/2.94(TM) ER:YAG LASER | Jun 11, 1997 | Substantially Equivalent |
| K963340 | MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE | May 12, 1997 | Substantially Equivalent |
| K961006 | MEDLITE/755 ALEXANDRITE LASER SYSTEM | Sep 11, 1996 | Substantially Equivalent |
| K961748 | MEDLITE/ERBIUM LASER SYSTEM | Jul 26, 1996 | Substantially Equivalent |