FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BCLEAR
K Number: K021762
·
Decision Aug 23, 2002
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
43
Review Days
86
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Basic Information
- Device Name
- BCLEAR
- K Number
- K021762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumenis, Inc.
- Date Received
- May 29, 2002
- Decision Date
- August 23, 2002
- Product Code
- FTC
- 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | FDA class 2 | General, Plastic Surgery |
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| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | Dec 18, 2008 | Substantially Equivalent |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Sep 11, 2008 | Substantially Equivalent |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | Apr 7, 2006 | Substantially Equivalent |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | Mar 9, 2006 | Substantially Equivalent |