Isolaz
Isolaz 2 acne treatment tip is a disposable patient-contact accessory for the Isolaz system. The tip interfaces with the handpiece during treatment and is available in size variants for the…
Isolaz 2 acne treatment tip is a disposable patient-contact accessory for the Isolaz system. The tip interfaces with the handpiece during treatment and is available in size variants for the system’s vacuum and broadband-light delivery sequence.
The filed item identifies the large acne tip, supplied as one unit. Solta describes the Isolaz 2 system as combining vacuum extraction with broadband light, with disposable tips available for the platform.
Listed Item
Isolaz 2 Treatment TIP, Acne, Large, 1 E
Tip and Handpiece
The replaceable tip interfaces with the Isolaz handpiece during the system’s treatment sequence. Vacuum extraction and broadband light are delivered by the wider system, not generated by the tip itself.
The large acne tip is one disposable size option for Isolaz 2. Other tip sizes and application variants are separate accessories for the platform.
Who Else Makes It
Concentrated in Guangdong (11), Beijing (10), Hebei (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Shen Zhen HanShine Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Beijing Starlight Science & Technology Development Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Guangzhou Telefield Limited | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Beijing Adss Development Co., Ltd. | Beijing | Beijing | Manufacturer | 8 |
| Rejuva Fresh LLC | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 31. All 31 manufacturers in China registered for Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Record
| Listed by | Solta Medical, Inc., United States |
|---|---|
| FDA product code | ONF |
| Device type | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2023-02-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS2-KIT-ACC | In distribution | |
| IS2-LAMP-400 | In distribution | |
| IS2-HANDPIECE | In distribution | |
| IS2-TIP-AC-S-4 | In distribution | |
| IS-TC-4ZE | In distribution | |
| IS2-TIP-PFKIT-12 | In distribution | |
| IS2-CONSOLE-R | In distribution | |
| IS2-CART-220-R | In distribution | |
| IS2-TIP-AC-L-4 | In distribution | |
| IS2-TIP-AC-M-4 | In distribution | |
| IS2-CONSOLE | In distribution | |
| IS2-TIP-AC-L-1 | In distribution | |
| IS2-CART-110-R | In distribution | |
| IS2-TIP-AC-S-1 | In distribution | |
| IS2-TIP-AC-M-1 | In distribution | |
| IS2-LAMP-550 | In distribution | |
| IS2-CART-110 | In distribution | |
| IS2-TIP-AC-SC-12 | In distribution | |
| IS2-CATIP | In distribution | |
| IS2-HANDPIECE-R | In distribution | |
| IS2-CART-220 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Quantaforte | Quanta System Spa | 8 |
| Apolomed | Shanghai Apolo Medical Technology Co., Ltd. | 7 |
| Me | Iluminage Ltd | 7 |
| Remington | Spectrum Brands, Inc. | 6 |
| Silk’n | Home Skinovations, Ltd. | 6 |
| Huamei | Shandong Huamei Technology Co., Ltd. | 6 |
| Remington Products | Spectrum Brands, Inc. | 6 |
| Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science AND Technology Co., Ltd. | 5 |
| Iluminage | Iluminage Ltd | 5 |
| Luma Rx | Spectrum Brands, Inc. | 5 |
| Silk’n | Silkn Beauty Ltd. | 4 |
| TheraClear | Theravant Corporation | 4 |
Showing 12 of 133. All products under Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121515 | 2012-06-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.