FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABC HAIR REMOVAL SYSTEM
K Number: K060839
·
Decision Dec 7, 2006
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
24
Review Days
254
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Basic Information
- Device Name
- ABC HAIR REMOVAL SYSTEM
- K Number
- K060839
- 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
- Palomar Medical Technologies, Inc.
- Date Received
- March 28, 2006
- Decision Date
- December 7, 2006
- Product Code
- OHT
- 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 |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OHT), ordered by most recent decision date.
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
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IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
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FDA Class 2
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Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
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FDA Class 2
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IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
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Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
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IPL Hair Removal Device (Models: T31A, T32A)
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Other Clearances by Palomar Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130250 | QYAG LASER SYSTEM | May 3, 2013 | Substantially Equivalent |
| K120622 | PALOMAR VECTUS LASER | May 23, 2012 | Substantially Equivalent |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | Jun 22, 2011 | Substantially Equivalent |
| K103664 | PRIMUS AESTHETIC PLATFORM | Mar 17, 2011 | Substantially Equivalent |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | Sep 1, 2010 | Substantially Equivalent |
| K100270 | ARTISAN AESTHETIC SYSTEM | Mar 29, 2010 | Substantially Equivalent |
| K090195 | PALOMAR LUX1540 HANDPIECE | Nov 20, 2009 | Substantially Equivalent |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | Jul 3, 2007 | Substantially Equivalent |
| K063571 | PALOMAR LUX2940 HANDPIECE | Feb 9, 2007 | Substantially Equivalent |
| K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | Dec 6, 2006 | Substantially Equivalent |